louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06384859: Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy
Official title: Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Insertional Achilles Tendinopathy
Keywords: chronic insertional Achilles tendinopathy
extracorporeal shockwave therapy
platelet rich plasma
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:

Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?

Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.

Participants will:

* Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks
* Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score


Eligibility criteria: Inclusion Criteria:

* Diagnosed with insertional Achilles tendinopathy
* Had symptom more than 6 months
* Failed other standard conservative treatment (rest, medication, activity modification, stretching exercise, and heel lift orthosis)

Exclusion Criteria:

* Receive corticosteroid injection at the Achilles insertion
* History of infection around ankle and heel
* Has neurological deficit
* Has a contraindication for ESWT(hemophilia, coagulopathy or foot and ankle malignancy)

Primary outcomes:
measure: VAS
timeFrame: 6 week, 3 months, 6 months and 1 year after treatment
Secondary outcomes:
measure: VAS-FA
timeFrame: 6 week, 3 months, 6 months and 1 year after treatment
measure: FFI
timeFrame: 6 week, 3 months, 6 months and 1 year after treatment
measure: FAAM
timeFrame: 6 week, 3 months, 6 months and 1 year after treatment
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Ramathibodi hospital
state: Bangkok
Study officials:
References:
Clinical trial NCT06430359: Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
Official title: Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Wilson Disease
Keywords: Wilson disease
urinary copper
chelator
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
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 a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).

Brief summary: Wilson's disease (WD) is a genetic disorder characterized by an accumulation of copper in the body, mainly in the liver and brain. Patients suffering from this disease are monitored by liver function tests, blood copper levels, and 24-hour urinary copper determinations.

Treatment is based either on chelating the copper accumulated in the body using D-penicillamine or Trientine or on limiting intestinal copper absorption with zinc salts.

Monitoring copper elimination in urine collected over 24 hours is essential for estimating a patient's copper load, adapting treatment dosage, and detecting any copper deficiency.

Nevertheless, urine collection is often complicated for patients, given the obvious constraints of collecting urine over 24 hours. Without this, clinical decisions are usually made based on spot urine.

There is no official recommendation for monitoring urinary copper elimination other than on 24-hour urine.

According to studies on healthy volunteers under physiological conditions, urinary copper elimination occurs according to a circadian rhythm, with minimal copper elimination between 8 pm and 4 am and maximum between 8 am and noon.

The study would aim to find the period of the day best correlated with 24h urinary copper excretion


Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).
* Age ≥ 6 years and ≤70 years.
* Patient able to perform 24h urine.
* Current treatment with D-Pencillamine, Trientine or Zinc.
* Non-opposition of patient and/or legal representatives for minor patients.

Exclusion Criteria:

* Patients who had a change in treatment within the last 6 months before the inclusion
* Patients who have undergone liver transplantation
* Patients with known chronic renal failure (GFR \< 30 ml/min)
* Patients on long-term diuretic or corticosteroid therapy
* Persons deprived of liberty by a judicial or administrative decision
* Patient under judicial protection, unable to express consent

Primary outcomes:
measure: Correlation factor
timeFrame: Two 24-hour urine recollection
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant
state: Rhone
Study officials:
References:
Clinical trial NCT05927259: The Role of N-acetylcysteine as a Novel Adjuvant Treatment in Acute Organophosphorus Pesticide Poisoning
Official title: The Role of N-acetylcysteine as a Novel Adjuvant Treatment in Acute Organophosphorus.A Randomized, Clinical Trial in Poison Control Center -Ain Shams University Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Organophosphorus Poisoned Patients
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All patients admitted in the ICU of the PCC-ASUH due to acute poisoning by acute organophosphorus poisoning will be included in the study. The diagnosis of intoxication will be based on history of acute exposure , clinical examination and laboratory investigations. Patients will be randomly allocated into 2 equal groups.

Group 1 -. Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC) and Group 2 - Patients who will receive conventional treatment only

Detailed description: 40 patients with acute organophosphorus poisoning will be randomly assigned as control groups and study group in a 1:1 ratio ( 20 patients in each group). The diagnosis of acute organophosphorus intoxication will be based on history of acute exposure, clinical examination and laboratory investigations. Patients will be randomly allocated into 2 equal groups.

Group 1 - Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC) Group 2 - Patients who will receive conventional treatment only

Eligibility criteria: Inclusion Criteria:

All patients (above 16 years) admitted to the ICU of the PCC-ASUH due to acute poisoning by acute organophosphorus poisoning will be included in the study. The diagnosis of intoxication will be based on history of acute exposure, clinical examination and laboratory investigations. -

Exclusion Criteria:

* Based on the possibility of alteration in measured parameters and/or biomarkers, patients below 16 years or above 60 years Patients with history of diabetes, cardiac disease, respiratory, renal disease and hepatic disease.

Primary outcomes:
measure: mortality
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine Ain shams university
state: None Selected
city: Cairo
country: Egypt
facility: Faculty of Medicine
state: None Selected
city: Cairo
country: Egypt
facility: Poison Control Center Ain Shams University Hospitals
Study officials:
affiliation: faculty of medicine ain shams university
name: Sarah S Mohammed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03123159: Clinical Performance Evaluation of DxN HBV Assay
Official title: Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis B
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years of age or older with chronic HBV who will undergo antiviral therapy to treat HBV infections

Brief summary: The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population.

Detailed description: Same as brief summary.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older
* Subject has serological evidence of chronic HBV infection, and measurable HBV-DNA and ALT at baseline
* Subject will undergo treatment with tenofovir or entecavir for a minimum of 48 weeks

Exclusion Criteria:

* Co-infection with HIV or HCV at enrollment
* Subject has decompensated liver disease or liver cancer
* Prior participation in study
* Current or planned participation in an investigational drug or device study

Primary outcomes:
measure: Sustained Virologic Response (SVR)
timeFrame: Up to 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Lipid and Diabetes Research Center
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Philadelphia
country: United States
facility: Albert Einstein Medical School
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: University of Washington / Harborview Medical Center
state: Washington
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'universite de Montreal
state: Quebec
Study officials:
affiliation: Beckman Coulter
name: Lori Lofaro, MSHS
role: STUDY_CHAIR
References:
Clinical trial NCT00542659: Biochemical Marker to Predict the Recurrence of Atrial Fibrillation After Surgical Maze Procedure
Official title: Plasma ANP and NT-pro-BNP, Atrial Anatomical Change May Determine the Outcome of Maze Operation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Maze procedure
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-10-11
Enrollment: 86
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who have valvular heart disease with atrial fibrillation and are scheduled for operation

Brief summary: The role of plasma NT-proBNP, hsCRP, TIMP-1(Tissue inhibitors of MetalloProteinase-1),TGF-b, MMP-3(Matrix MetalloProteinase-3), and pro-MMP-1 in predicting the recurrence of AF after surgical Maze procedure.

The association of expression of CTGF, TGF-b, BNP, ANP, collagen-1, and collagen-3 in LA with the recurrence of AF after surgical Maze procedure.


Eligibility criteria: Inclusion Criteria:

* The patients who have valvular heart disease with atrial fibrillation and are scheduled for operation

Exclusion Criteria:

* Coronary heart disease
* Congestive heart failure

Primary outcomes:
measure: AF recurrence
timeFrame: year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Young Keun On, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06993259: Effect of Virtual Reality and Serious Games on Pain, Fear, Anxiety, and Satisfaction During Skin Prick Testing in Children
Official title: Comparison of the Effectiveness of Virtual Reality and Serious Games on Pain, Fear, Anxiety, and Satisfaction During Skin Prick Testing in Children Aged 6-12 Years: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Fear
Allergy
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research was designed as a randomized controlled trial with a parallel-group structure (intervention-control) to examine the effects of serious gaming and virtual reality interventions on reducing pain, fear, and anxiety levels, as well as improving care satisfaction among children aged 6-12 years who underwent skin prick tests.
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial evaluated the effectiveness of virtual reality (VR) and serious gaming (SG) in reducing pain, fear, and anxiety, and improving satisfaction during skin prick testing (SPT) in children aged 6-12 years. A total of 90 children were randomly assigned to three groups: standard care (control), VR, or SG. The VR group watched a 360° animated video using a headset, while the SG group played Subway Surfers on a tablet. Pain (WBFPS), fear (CFS), anxiety (CAS-S), and satisfaction (VAS) were measured post-procedure.


Eligibility criteria: Inclusion Criteria:

* Children aged 6 to 12 years
* Scheduled to undergo an allergy skin prick test
* No visual impairments
* No use of anxiolytic or analgesic medication within the past six hours
* Voluntary agreement to participate (child assent and parental consent)

Exclusion Criteria:

* Not within the 6-12 age range
* Not scheduled for an allergy skin prick test
* Presence of visual impairments
* Use of anxiolytic or analgesic medication within the past six hours
* Refusal to participate

Primary outcomes:
measure: Wong-Baker Facial Expression Rating Scale
timeFrame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
measure: Child Fear Scale
timeFrame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
measure: Child Anxiety State Scale
timeFrame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
Secondary outcomes:
measure: VAS Care Satisfaction Score
timeFrame: Immediately after the skin prick test procedure (within 1-2 minutes post-intervention)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University
Study officials:
References:
Clinical trial NCT05337059: Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients.
Official title: Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients..
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ARDS, Human
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-04-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: feasibility, monocentric, prospective study
Primary purpose: TREATMENT

Brief summary: Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

Detailed description: Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. A positive expiratory transpulmonary pressure may be considered as a target to limt the risk of collapse in dependant lung regions. Some authors propose to titrate PEEP to target an inspiratory transpulmonary pressure of 20cmH20 to limit the risk of overdistension in non-dependant regions.The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Moderate to severe ARDS
* Written informed consent obtained from patient' surrogates

Exclusion Criteria:

* Pneumothorax
* Known pregnancy
* Contraindication to electrical impedance tomography or esophageal pressure measurements

Primary outcomes:
measure: Ventilation strategy failure
timeFrame: 48 hours
Secondary outcomes:
measure: Short term physiologicals effects on hemodynamics
timeFrame: 45 minutes
measure: All-cause mortality at day 28
timeFrame: 28 days
measure: Ventilator-free days at day 28
timeFrame: 28 days
measure: Short term physiologicals effects on respiratory mechanics
timeFrame: 45 minutes
measure: Short term physiologicals effects on gas exchange
timeFrame: 45 minutes
measure: Short term physiologicals effects on gas exchange
timeFrame: 45 minutes
measure: Short term physiologicals effects on gas exchange
timeFrame: 45 minutes
measure: Short term physiologicals effects on respiratory mechanics
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
Study officials:
References:
Clinical trial NCT00785759: Brain Uptake and Safety With Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers
Official title: An Open-label Study to Assess Brain Uptake and Safety of AH110690 (18F) Injection in Subjects With Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Amnestic Mild Cognitive Impairment
Keywords: Alzheimer's Disease
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: i3 Statprobe
name: Medpace, Inc.
name: Hvidovre University Hospital
First posted: 2008-11-05
Enrollment: 78
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study to Assess Brain Uptake and Safety of AH110690 (18F) Injection in Subjects with Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers.


Eligibility criteria: Inclusion Criteria:

* The subject meets National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for clinically probable AD and Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for dementia of Alzheimer's type.
* The subject meets Petersen criteria for amnestic MCI.
* The subject has no evidence of cognitive impairment by medical history.

Exclusion Criteria:

* The subject may not be able to complete the study as judged by the investigator.
* The subject has received ionising radiation exposure from clinical trials in the last 12 months or has participated in any other clinical study within 30 days of study entry.
* The subject has known allergies to \[18F\]AH110690 or \[11C\]PIB or their constituents.
* The subject is pregnant or breast-feeding.
* The subject has a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records.
* The subject has a contraindication for MRI (including, but not limited to, claustrophobia, pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant).
* The subject has a history of head injury with loss of consciousness.

Primary outcomes:
measure: Examine the efficacy and determine visual assessment of raised [18F] brain uptake for separating subjects with probable Alzheimer's Disease from healthy volunteers and assigning amnestic mild cognitive impairment cases to an AD or HV category.
timeFrame: September 2008 - February 2009
Secondary outcomes:
measure: Examine the efficacy and parameters of brain [18F] uptake for separating 25 subjects with probable AD from 25 HV, assigning 20 amnestic MCI cases to an AD or HV category by measuring ranges of regional cerebral to cerebellum tracer uptake ratios.
timeFrame: September 2008 - February 2009
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: GE Healthcare
Study officials:
affiliation: GE Healthcare
name: Carl G Torres, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01889459: Japanese CTO PCI Expert Registry
Official title: Patient Registry of Percutaneous Coronary Intervention (PCI) for Chronic Total Occlusion (CTO) by Japanese Experts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Total Occlusion of Coronary Artery
Lead sponsor: Kurashiki Central Hospital
Sponsor class: OTHER
Collaborators: name: Japanese CTO PCI Expert Registry investigators
First posted: 2013-06-28
Enrollment: 19000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent PCI for CTO lesions by Japanese certified operators

Brief summary: The purpose of this study is to establish a consensus of treatment strategy of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) through patient registry of PCI for CTO performed by Japanese certified operators.


Eligibility criteria: Inclusion Criteria:

Patients eligible for PCI

Patients who underwent PCI for CTO lesions that contain the following:

1. Thrombolysis in myocardial infarction trial (TIMI) 0
2. The occlusive period more than 3 months or unknown
3. The main coronary arteries (segment 1-3, 5-8, 11, 13), branches that have large perfusion area (segment 4PL, 9/10, 12) and graft

Exclusion Criteria:

Patients ineligible for PCI judged in clinical practice

Primary outcomes:
measure: successful revascularization without any major adverse cardiocerebral events (MACCE) at early follow-up and MACCE during the 5-year follow-up
timeFrame: within the first 1 month (plus 1 month) after PCI and during the 5-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
Study officials:
References: