louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02826005: Examination the Ability to Early Diagnose HCC by Combining Three Biomarkers Technology Developed by WAKO, And Their Relevance to Cirrhotic of Patients With Various Backgrounds and the Israeli Population.
Official title: Examination the Ability to Early Diagnose HCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibrosis
Lead sponsor: Ilex Medical
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Examination the ability to early diagnose HCC by combining three biomarkers technology developed by WAKO, And their relevance to cirrhotic of patients with various backgrounds and the Israeli population.

This blood test will serve as an additional diagnostic tool tools currently in use (Ultrasound and AFP levels) to cirrhotic patients with high risk to develop hepatocellular carcinoma.

Another group that will be examined for all three biomarkers will be patients which already diagnosed with hepatocellular carcinoma, and have normal AFP level in order to examine the correlation between the presence of tumor, the number of them and the tumor size and the three biomarkers concentration in their blood


Eligibility criteria: Inclusion Criteria:

* patients with chronic liver disease or cirrhotic or with diagnoses HCC with HCV, HBV, NAFLD, Alcohol background

Exclusion Criteria:

* patients with chronic liver disease or cirrhotic or with diagnoses HCC with autoimmune background or other background than HCV, HBV, NAFLD and Alcohol.

Primary outcomes:
measure: Diagnosis of HCC in cirrhotic patients with positive values of the bio-markers by MRI
timeFrame: within 3 years from the bio-markers examination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06823505: Lung Cancer Patients and Parent-child Interaction Experience and Process
Official title: Lung Cancer Patients and Parent-child Interaction Experience and Process
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer Patients
Parent-child Interaction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 109
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced lung cancer aged 40 to 64 years, and have aged 10 to 19 years old teenagers.

Brief summary: Type of study: The goal of this observational study is to explore the relationship between patients with advanced lung cancer and their parent-child interactions during the treatment process, and to understand the impact of the degree of self-differentiation of parents with advanced lung cancer on the physical and mental health of their children. The main questions it aims to answer are:

1. To explore the post-illness adjustment process of patients with advanced lung cancer and the changes in the parent-child relationship among adolescents.
2. To explore the changes in demographic factors-self-belief, mental health, and self-efficacy among patients with advanced lung cancer-and the parent-child relationship among adolescents.
3. Explore the family resilience of patients with advanced lung cancer - family peer relationships, and the interaction between parent-child relationships among adolescents.

Detailed description: This study explores the relationship between late-stage lung cancer patients and their parent-child interactions during the treatment process, and understands the impact of the degree of self-differentiation of parents with late-stage lung cancer on their children's physical and mental health.

Eligibility criteria: Inclusion Criteria:

1. Patients with advanced lung cancer aged 40 to 64 years (mid-adulthood).
2. There are lung cancer patients in the family who are teenagers aged 10 to 19 years old.
3. Those who voluntarily participate in this study.
4. Voluntary participants can express themselves orally and in handwriting.

Exclusion Criteria:

1. Single lung cancer patients over 65 years old.
2. Lung cancer patients under 40 years old.
3. Patients diagnosed with early-stage lung cancer.
4. Those who have cognitive impairment and are unable to understand the problem.
5. Those who are unable to express and respond to questions.

Primary outcomes:
measure: Parent-child interaction
timeFrame: one years
measure: Center for Epidemiological Studies Depression Scale
timeFrame: one years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Nation Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05238805: Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake
Official title: Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketoses, Metabolic
Keywords: ketones
heart metabolism
kidney metabolism
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Nestlé Health Science Spain
First posted: 2022-02-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Participants will have to perform 2 scans one after the other
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to make a comparison between 11C-acetate and 11C-Acetoacetate heart and kidney metabolism

Detailed description: Healthy people will have two positron emission tomography scan to perform. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The results will allow to determine if both tracers are used in a similar way but the organs and see if the investigators can use the already validated analyse method for acetate to make acetoacetate analysis

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 55
* BMI between 18,5 and 28
* Healthy
* Normal value for blood pressure

Exclusion Criteria:

* Taking drugs that could influence metabolism
* Diabetes or prediabetes
* Pregnancy or lactation
* Participation in a intensive sport program
* Being on a ketogenic diet
* Any clinical abnomally in prescreen blood sample

Primary outcomes:
measure: Mean in left ventricule myocradial blood flow
timeFrame: 30 minutes
measure: Mean in left ventricule myocardial blood flow
timeFrame: 30 minutes
measure: Mean in Kidney acetate uptake
timeFrame: 30 minutes
measure: Mean in Kidney acetoacetate uptake
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Center on Aging
state: Quebec
Study officials:
References:
Clinical trial NCT04347005: The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Arthrosi Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-04-15
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.


Eligibility criteria: Inclusion Criteria:

* Serum uric acid level ≥ 4.5 mg/dL (268 µmol/L)
* Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
* Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures

Exclusion Criteria:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* History and/or presence of drug addiction or excessive use of alcohol

Primary outcomes:
measure: To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Safety Analyses
timeFrame: 8 Days
measure: Area under the curve (AUC) for plasma AR882
timeFrame: 6 Days
measure: Time to maximum plasma concentration (Tmax) for AR882
timeFrame: 6 Days
measure: Maximum plasma concentration (Cmax) for AR882
timeFrame: 6 Days
measure: Apparent terminal half-life (t1/2) for AR882
timeFrame: 6 Days
measure: Amount excreted (Ae) into urine for AR882
timeFrame: 6 Days
measure: Fractional Excretion (FEUA) for AR882
timeFrame: 6 Days
Secondary outcomes:
measure: PD profile of a single dose of AR882
timeFrame: 6 Days
measure: PD profile of a single dose of AR882 in combination with allopurinol
timeFrame: 6 Days
measure: PD profile of a single dose of AR882 in combination with febuxostat
timeFrame: 6 Days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty, Ltd.
state: Victoria
Study officials:
References:
Clinical trial NCT02125305: Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly
Official title: A Phase I Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in Elderly Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Elderly
Keywords: Metformin
Pharmacokinetics/ Pharmacodynamics
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 12
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral administration in healthy elderly male volunteers.


Eligibility criteria: Inclusion Criteria:

* Males aged 65-85 years with a body mass index (BMI) of 18-28 kg/m2
* Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations including hematology (blood cell count, hemoglobin, and platelet count), liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin), serum creatinine, blood glucose and urinalysis

Exclusion Criteria:

* If they had clinically relevant disorders
* Past history of diabetes or clinical findings to suspect diabetes
* Abnormal clinical laboratory values (i.e., platelets ≤ 75,000/mm3, hemoglobin ≤ 9 g/dL, neutrophils absolute ≤ 1000/mm3, fasting glucose \> 126mg/dL, creatinine ≥ 1.5 mg/dL, or AST, ALT \> 3 × upper limit of normal)

Primary outcomes:
measure: AUC(area under the plasma concentration-time curve)
timeFrame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose
Secondary outcomes:
measure: AUGC(total area under the serum concentration-time curve for glucose concentration)
timeFrame: predose and 15, 30, 45, 60, 90, 120 min oral glucose tolerance test
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang hospital
name: Jae-Yong Chung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03591705: TACE-HAIC vs. HAIC for Potentially Resectable HCC
Official title: Transarterial Chemoembolization Versus Transarterial Chemoembolization With Hepatic Artery Chemotherapy Infusion for Patients With Potentially Resectable HCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Potentially Resection
Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to large tumors, surgical treatment is suitable for early-stage and well-reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of potentially resectable HCC.

EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for HCC patients. Several clinical studies showed that HAIC bring better tumor response rate that the conditional TACE. The combination of TACE with HAIC (TACE-HAIC), theoretically can significantly increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC and TACE-HAIC for those patients.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Diagnosed as potentially resectable with consensus by the panel of liver surgeons
* stage BCLC A/B, without extra-hepatic involvement
* No previous anti-HCC treatment
* Eastern Co-operative Group performance status 2 or less
* Liver function: Child's A or B (score \< 7)

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* underlying serve cardiac or renal diseases
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Patients ineligible for hepatic artery embolization

Primary outcomes:
measure: progression-free survival
timeFrame: 6-12 months
Secondary outcomes:
measure: overall survival
timeFrame: 6-12 months
measure: Downstage hepatectomy rate
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yunfei Yuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01748305: Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus
Official title: Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Exercise
Keywords: GDM
A1GDM
A2GDM
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with newly diagnosed gestational diabetes will be recruited. The control group with get routine diet and exercise counseling. The intervention group will be instructed to get moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with supervision in order to be instructed how hard to work. All participants will keep an exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is glucose control, specifically the need for medication in treatment of their diabetes. The hypothesis is that moderate or greater intensity exercise will better control glucose and lead to less need for medication management.


Eligibility criteria: Inclusion Criteria:

* gestational diabetes mellitus
* singelton pregnancy
* 18 years old or older
* no medical contraindications to exercise

Exclusion Criteria:

* multiple gestation
* non-English speaking
* unable to exercise
* preexisting diabetes

Primary outcomes:
measure: Need for medication for diabetes
timeFrame: 3 weeks
Secondary outcomes:
measure: Birth weight
timeFrame: delivery
measure: A1c
timeFrame: delivery
measure: Mode of delivery
timeFrame: delivery
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Antonio Frias, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Jessica Voge, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02217605: 31P Magnetic Resonance Spectroscopy Fructose Study
Official title: Investigating the Effects of an Oral Fructose Challenge on Hepatic ATP Reserves in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: NAFLD
Oral Fructose Challenge
31P MRS
Liver
Subjects
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Biotechnology and Biological Sciences Research Council
name: Unilever R&D
First posted: 2014-08-15
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effects of an oral fructose challenge on liver adenosine triphosphate (ATP) reserves using 31P magnetic resonance spectroscopy (MRS) as a potential measure measure of liver health.

Detailed description: This study uses 31P spectra acquired from the liver in healthy subjects following a fructose drink to monitor ATP levels. This is also related to baseline BMI, liver glycogen and liver lipid levels

Eligibility criteria: Inclusion Criteria:

* Male
* Age 18 - 30
* BMI 20 - 27 kg/m\^2
* Healthy

Exclusion Criteria:

* Smokers
* Liver disease or Metabolic Disorders
* Metal implants (not suitable for MRI)

Primary outcomes:
measure: Hepatic ATP reserves following an oral fructose challenge
timeFrame: 2 hours post prandial
Secondary outcomes:
measure: Correlate hepatic ATP depletion / recovery with BMI, liver lipids and liver glycogen
timeFrame: 2 hours post prandial
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Luca Marciani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05019105: Phase 1 ALKS 1140 in Healthy Adults
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Escalating Doses of ALKS 1140 With a Pilot Evaluation of Food Effect in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Central Nervous System Diseases
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18 and \<30 kg/m2

Exclusion Criteria:

* Clinically significant illness or disease including significant cardiac, gastrointestinal (stomach)
* Subjects who have known allergic reactions to food or medications
* Women of childbearing potential
* Any clinically significant lifetime history of suicidal behavior or ideation (thoughts)
* Subject had lymphoma, leukemia, or any malignancy within the past 5 years

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: Up to 28 days
measure: Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to 28 days
measure: 12-lead safety ECG results
timeFrame: Up to 28 days
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) for ALKS 1140
timeFrame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
measure: Time to Cmax (Tmax)
timeFrame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
measure: Half-life (t1/2) of ALKS 1140
timeFrame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
measure: Time until first quantifiable concentration (tlag)
timeFrame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
measure: Area under the concentration-time curve (AUC)
timeFrame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
measure: Apparent volume of distribution at terminal phase (Vz/F)
timeFrame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29
measure: Apparent total clearance following oral administration (CL/F)
timeFrame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
measure: Change from baseline in QTcF (Fridericia method) interval in response to treatment (Holter monitoring)
timeFrame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
measure: Accumulation Index (RA)
timeFrame: Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Alkermes Clinical Investigative Site
Study officials:
References: