louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06918054: Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia
Official title: Hepatoprotective Measures for Children and Adolescents With Acute Lymphoblastic Leukemia During Induction Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Leukaemia (Acute)
Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
Hepatoprotective program
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 42
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Implementation of a proposed whole program of monitoring and prevention of acute hepatic injury during the time of induction chemotherapy in children and adolescent with ALL.
Primary purpose: PREVENTION

Brief summary: This current study will implement a proposed whole program of monitoring and prevention acute hepatic injury during the time of induction chemotherapy in children and adolescent with ALL.

Detailed description: Children and adolescent with acute lymphoblastic leukemia (ALL) can exhibit a wide spectrum of hepatotoxicity ranging from asymptomatic to clinically significant during induction chemotherapy. Unmonitored hepatic status can lead to a hepatic toxicity that might result in unwarranted interruption of the aimed delivery of dose dense chemotherapy to induce remission and consequent treatment.

To evaluate the effect of chemotherapy in children and adolescent with ALL during induction phase, through recording liver function tests before, during and after induction chemotherapy.

Eligibility criteria: Inclusion Criteria:

Children and adolescents aged from 2 to 18 years newly diagnosed with acute lymphoblastic leukemia during induction phase of chemotherapy treated at Ain Shams

Exclusion Criteria:

Known chronic liver disease.

Primary outcomes:
measure: Implementation a program of hepatic support
timeFrame: Almost 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)
Study officials:
affiliation: Faculty of Medicine Ain Shams University
name: Manal El-Sayed, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00659854: Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)
Official title: Cow's Milk Allergy in Infants With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: obstructive sleep apnea syndrome
The study examines the response of infants diagnosed with obstructive sleep apnea syndrome to diet changes
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cow's milk allergy may be involved in the evolution of sleep apnea in infants. The study will assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant. Specifically , infants will be investigated by sleep studies in order to test this hypothesis.


Eligibility criteria: Inclusion Criteria:

1. Polysomnographically diagnosed OSA
2. Age is 2-24 months
3. Clinical suspicion of milk allergy due to findings in the medical history or physical exam

Exclusion Criteria:

1. Congenital defects in the pulmonary and gastrointestinal systems
2. Family history of genetic diseases or familial syndromes
3. Infantile asthma.

Primary outcomes:
measure: Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change).
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical center
Study officials:
affiliation: Soroka University Medical Center
name: Aviv D Goldbart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06960954: PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma
Official title: Prothrombin Induced by Vitamin K Absence II (PIVKA-II) Serum Level as a Predictor for Portal Vein Tumor Thrombosis in Hepatocellular Carcinoma Patients.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepato Cellular Carcinoma (HCC)
Portal Vein Tumour Thrombosis
Keywords: PIVKA-II
Portal vein tumor thrombosis
Hepatocellular carcinoma
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cross-sectional study will be carried out on 116 patients attending the Tanta Tropical Medicine Outpatient Clinic, Faculty of Medicine. The start of the research will be in January 2025 to December 2025 or until the collection of the cases.

Brief summary: The goal of this cross-sectional observational study is to evaluate the relation between Prothrombin induced by vitamin K absence II (PIVKA-II) and the presence of portal vein tumor thrombosis (PVTT) in hepatocellular carcinoma (HCC) patients.

Researchers will compare PIVKA-II serum levels in HCC patients with PVTT and without PVTT.

Participants will undergo history-taking, clinical examination, laboratory investigations, PIVKA-II serum level, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, and Triphasic CT abdomen with contrast or MRI to evaluate tumor site, size, number, and presence of PVTT (a filling defect in the portal vein or its branch to distinguish PVTT or thrombus).


Eligibility criteria: Inclusion Criteria:

* Male or female patients older than 18 years.
* Patients with confirmed HCC with or without PVTT (Diagnosed by two imaging modalities or one imaging modality with elevated serum alpha fetoprotein or liver biopsy).

Exclusion Criteria:

* Prior locoregional therapy or liver transplantation.
* Patients on vitamin K, vitamin K antagonists or antibiotics.
* Patients with cholestasis.
* Patients with renal insufficiency.
* Patients with other malignancies.
* Unwilling to participate in our study.

Primary outcomes:
measure: PIVKA-II serum level for prediction of PVTT in HCC patients.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbyea
Study officials:
affiliation: Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
name: Rania M Elkafoury, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04377854: Prognostic Value of BNP in MCS - a 25 Year Follow up Study
Official title: The Prognostic Value of proBNP in Patients Supported With Durable Mechanical Circulatory Assist Devices - a 25 Year Follow up Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Left Ventricular Assist Device
Prognosis
Durable Mechanical Support Device
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred for evaluation for advanced HF treatment at the Rigshospitalet in Denmark. All patients with Advanced HF (regardless of type of adv HF treatment) at the contributing center will (hopefully) be included in this study.

Brief summary: A biobank has been created to investigate the prognostic value of biomarkers (mainly BNP) in patients implanted with durable mechanical assist devices comparing patients with advanced HF supported by MCS with those who are transplanted and those who remain on optimal medical therapy.

Patients will be followed up for 25 years after inclusion.

Detailed description: All patients referred for advanced HF treatment at the Dept of Cardiology at Rigshospitalet.

Eligibility criteria: Inclusion Criteria:

* All patients referred for evaluation for advanced HF treatment at the Rigshospital in Denmark
* Age\>18 years

Exclusion Criteria:

* No consent

Primary outcomes:
measure: Alive
timeFrame: 25 years from inclusion
measure: Dead
timeFrame: 25 years from inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: DK
Study officials:
References:
Clinical trial NCT05824754: An App to Reduce Cannabis Use Among Emerging Adults
Official title: Pilot Project 1. Feasibility Pilot of a JITAI to Reduce Cannabis Use Among Emerging Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Keywords: Cannabis Use
Marijuana
Substance-Related Disorders
Mental Disorders
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-04-24
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is being completed to pilot prevention methods to promote wellness and reduce risky behaviors, including the use of substances such as cannabis. This study will help researchers learn about ways of delivering this information that is both appealing and helpful to young adults who use mobile apps.


Eligibility criteria: Inclusion Criteria:

* Reside in the US
* Speak and read English
* Have a smartphone on which the app can be downloaded
* Screen positive for cannabis use 3 or more times each week over the past month
* Report motivation to change cannabis as 1 or higher (using scale of 0-10)
* Meet Study verification criteria (i.e., use of CAPTCHA, IP address checks)

Exclusion Criteria:

* Use of Medical Cannabis
* Failure to meet study verification criteria

Primary outcomes:
measure: App Feasibility
timeFrame: 1 month
measure: App Acceptability
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT04150354: Mental Health Symptom Monitoring Utilizing the Cogito Behavioral Analytic Platform
Official title: Mental Health Symptom Monitoring Utilizing the Cogito Behavioral Analytic Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobile Applications
Cell Phone Use
Mental Health Issue
Acceptability of Health Care
Feasibility
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2019-11-04
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary objective of this project is to test the acceptability and feasibility of a mobile application to facilitate mental health symptom monitoring and follow-up among Veterans. During the course of the study, the research application will be installed on participants' mobile phone. The application on the participants' phone will be recording data about their behavior. Participants will also be asked to complete bi-weekly surveys via the app.


Eligibility criteria: Inclusion Criteria:

* Veterans between the ages 18-89 years of age at the time of enrollment
* able to provide signed and dated informed consent
* has anandroid platform phone and is willing to use phone and personal data plan to participate

Exclusion Criteria:

* Participation in conflicting Rocky Mountain MIRECC interventional protocol

Primary outcomes:
measure: Client Satisfaction Questionnaire -8
timeFrame: 3 months
measure: Narrative Evaluation of Intervention Interview (NEII).
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: VAECHCS
state: Colorado
Study officials:
References:
Clinical trial NCT05988554: Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products
Official title: Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess Hibiscus sabdariffa extract and collagen products on skin condition improvement


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 4 weeks.
* Constant drug use
* Students who are currently taking courses taught by the principal investigator of this trial.

Primary outcomes:
measure: The change of skin collagen density
timeFrame: Week 0, week 4, week 8
measure: The change of skin wrinkles
timeFrame: Week 0, week 4, week 8
measure: The change of skin texture
timeFrame: Week 0, week 4, week 8
measure: The change of skin elasticity
timeFrame: Week 0, week 4, week 8
measure: The change of skin moisture
timeFrame: Week 0, week 4, week 8
Secondary outcomes:
measure: The change of skin melanin index
timeFrame: Week 0, week 4, week 8
measure: The change of skin L* value
timeFrame: Week 0, week 4, week 8
measure: The change of transepidermal water loss (TEWL)
timeFrame: Week 0, week 4, week 8
measure: The change of skin pores
timeFrame: Week 0, week 4, week 8
measure: The change of skin spots
timeFrame: Week 0, week 4, week 8
Other outcomes:
measure: The change of self-assessment skin condition
timeFrame: Week 0, week 4, week 8
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy ＆ Science
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Science
name: Chia-Hua Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00769054: Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study
Official title: Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Prolapse
Keywords: Postoperative pain
PONV
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare systematic local infiltration with ropivacaine or placebo in patients undergoing repair of posterior vaginal wall prolapse.

The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.


Eligibility criteria: Inclusion Criteria:

* eligible for elective repair of posterior vaginal wall prolapse
* able to speak and understand Danish
* able to give informed consent

Exclusion Criteria:

* alcohol or medical abuse
* allergies to local anesthetics
* age \< 18 yrs.
* intolerance to opioids

Primary outcomes:
measure: Postoperative Pain during rest, coughing and ambulation
timeFrame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively
Secondary outcomes:
measure: Postoperative Nausea and Vomitus
timeFrame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
affiliation: Hvidovre University Hospital
name: Billy B Kristensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01201954: Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning
Official title: Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: pain
sucrose
newborn
mechanical ventilation
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 43
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of preterm infants during endotracheal suctioning.

Detailed description: Many infants admitted to neonatal intensive care unit (NICU) undergo repeated invasive procedures. Recent studies have shown that the oral sucrose administration to neonates is safe and effective for pain relief during heel stick and venipuncture.Most data suggest the investigation of the effect of sucrose in other painful procedures such as in ventilated newborns.

Eligibility criteria: Inclusion Criteria:

* preterm infants
* over 12 hours of life
* intubated
* clinically stable
* without use of analgesics or sedatives

Exclusion Criteria:

* preterms with congenital malformations
* preterms with genetic syndromes
* preterms with Apgar score at 5´\<7
* preterms with meningitis
* preterms with diagnosed of necrotizing enterocolitis Ouvir Ler foneticamente

Primary outcomes:
measure: clinical pain score
timeFrame: within the first twelve hours after clinical stabilization, the PIPP will be done.
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Hospital Agamenon Magalhães, Hospital Barão de Lucena
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Rita A Almeida, postgraduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Pernambuco
name: Sônia B Coutinho, Dr.
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Pernambuco
name: Pedro I Lira, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02278354: Tau Imaging in Professional Fighters
Official title: 18F-AV-1451 PET Imaging in Professional Fighters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2014-10-30
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive flortaucipir to explore its use as a biomarker for brain injury related to repetitive head trauma and to examine the relationship between clinical presentation and tau deposition.


Eligibility criteria: Inclusion Criteria:

All Subjects

* Currently enrolled in the PFBHS protocol and have participated in a minimum of 10 professional fights
* Can tolerate Positron Emission Tomography (PET) scan procedures
* Have the ability to provide informed consent

Subjects with cognitive impairment

* Have subjective cognitive complaints or objective decline or impairment as determined by the investigator

Exclusion Criteria:

* Have behavior dysfunction that is likely to interfere with imaging
* Are claustrophobic or otherwise unable to tolerate the imaging procedure
* Have current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
* A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation
* Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
* Have current drug or alcohol dependence or alcohol dependence within the past 2 years

Primary outcomes:
measure: Flortaucipir Imaging (Quantitative) Between Cognitive Groups
timeFrame: baseline scan
measure: Flortaucipir Imaging (Quantitative) Between Fighter Groups
timeFrame: baseline scan
measure: Flortaucipir Imaging (Qualitative) Between Cognitive Groups
timeFrame: baseline scan
measure: Flortaucipir Imaging (Qualitative) Between Fighter Groups
timeFrame: baseline scan
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
Study officials:
References: