louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03166514: Glycemic Response of a Commercial Food Bar
Official title: Pharmacokinetic and Glycemic Response of a Commercially Available Food Bar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose and Insulin Response
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Nutrabolt
First posted: 2017-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, cross-over administration of supplements with approximately 5-10 days between testing sessions.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine the glucose and insulin response to a food bar.

Detailed description: Fitjoy is a commercially available food bar marketed as having a low glycemic index and being relatively high in dietary fiber. The fiber contained within this product is isomalto-oligoshaccaride (IMO) which is a food ingredient with a relative sweetness level equal to approximately 60% of sucrose. Chemically, IMO is a mixture of glucose oligomers with alpha - (1-6) - linkages. To date, no research has been performed on the glycemic response to ingesting IMO in combination with other constituents. Therefore the purpose of this study is to determine the glycemic index of the Fitjoy bar.

Eligibility criteria: Inclusion Criteria:

* Participant is between the ages of 18 and 35
* Participant is apparently healthy
* Participant is moderately active and participants in low intensity recreational activity at lease 3 to 4 days a week
* Participant has a BMI \< 24.9

Exclusion Criteria:

* Participant has a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmais, cardiovascular disease
* Participant uses current prescription medication (birth control is allowed)
* Participant is pregnant or nursing or plans to become pregnant during the next month
* Participant has an intolerance to caffeine and/or other natural stimulants
* Participant has a history of smoking
* Participant drinks excessively (i.e., 12 drinks per week or more)

Primary outcomes:
measure: How a commercially available food bar affects blood glucose levels
timeFrame: One day
measure: How a commercially available food bar affects blood insulin levels.
timeFrame: One day
Secondary outcomes:
measure: Does a commercially available food bar cause hypoglycemia
timeFrame: One day
measure: Does a commercially available food bar cause dizziness
timeFrame: One day
measure: Does a commercially available food bar cause headaches
timeFrame: One day
measure: Does a commercially available food bar cause fatigue
timeFrame: One day
measure: Does a commercially available food bar cause stomach upset
timeFrame: One day
Other outcomes:
Locations:
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03841214: Study on Prediction of Left Ventricular Remodeling Using ST2
Official title: Prediction of ST2 for impRovement of Left ventricUlar Systolic funcTion After Percutaneous Coronary Intervention in Patients With acutE Coronary synDrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 114
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute coronary syndrome who underwent successful percutaneous coronary intervention

Brief summary: Patients who underwent percutaneous coronary intervention after diagnosis of acute coronary syndrome should be enrolled in the study and follow - up.

Detailed description: Obtain written consent for patients who meet all of the selection criteria and who do not meet the exclusion criteria.

ACS(Acute Coronary Syndrome) patients with LV systolic dysfunction(LVEF\<50%) on TTE test who underwent successful PCI. At that time, patient proceed with the Baseline blood test(ST2) in hospital.

And then, Medical therapy for 3 months later patient proceed with the Follow-up blood test(ST2) and TTE in OPD.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 19 or older
* Patients with acute coronary syndrome who underwent successful percutaneous coronary intervention
* Patients with left ventricular ejection fraction less than 50% on transthoracic echocardiography
* Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

* Failure to obtain TIMI 3 flow after procedure
* If the remaining life span is less than one year
* Women who are breastfeeding or plan to become pregnant or are planning to become pregnant during the study period

Primary outcomes:
measure: ST2 and LV end-diastolic volume index
timeFrame: 3 months
Secondary outcomes:
measure: ST2 and LV ejection fraction
timeFrame: 3 months
measure: ST2 and E over e' ratio
timeFrame: 3 months
measure: ST2 and LV wall motion score
timeFrame: 3 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Dalseogu
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Hyung-Seop Kim, Postdoctoral
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04831814: Narrow Band Imaging in Diagnosis of Colorectal Polyps
Official title: Near-focus Versus Normal-focus Narrow Band Imaging Colonoscopy in Diagnosis of Colorectal Polyps Based on Combined NICE and WASP Classification: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Polyp
Colorectal Neoplasms
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 118
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: DIAGNOSTIC

Brief summary: Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively.

Detailed description: Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF and SF. There were few studies comparing diagnostic accuracy between NF and SF in the diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard.

Eligibility criteria: Inclusion Criteria:

* Patients who were scheduled for colonoscopy at NKC institute

Exclusion Criteria:

* Inflammatory bowel disease
* Polyposis syndrome
* Colorectal cancer
* Active gastrointestinal bleeding
* Pregnant woman
* Inadequate bowel preparation
* Contraindication for polyps removal

Primary outcomes:
measure: Rate of accurate polyp histology predictions by the Endoscopists in the two groups.
timeFrame: At the time of procedure
measure: Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups.
timeFrame: At the time of procedure
Secondary outcomes:
measure: The polyp detection rate
timeFrame: At the time of procedure
measure: The adenoma detection rate
timeFrame: At the time of procedure
measure: Diagnostic Characteristics
timeFrame: At the time of procedure
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Prince Songkla University
state: Songkhla
Study officials:
affiliation: NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University
name: NISA NETINATSUNTON, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03663114: A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma
Official title: A Drug Use Investigation of LENVIMA 4 mg Capsules - A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Patients With Unresectable Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular Carcinoma
Lenvima
Post-marketing surveillance
LEN02T
Lenvatinib Mesilate
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 713
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants with unresectable hepatocellular carcinoma and administered lenvatinib in Japan will be observed prospectively.

Brief summary: This study is a post-marketing observational study of lenvatinib in participants with unresectable hepatocellular carcinoma. The primary objective of this study is assessment of risk factors for hepatic encephalopathy.


Eligibility criteria: Inclusion Criteria:

* Participants with unresectable hepatocellular carcinoma who were administered the lenvatinib mesilate for the first time within the registration period.
* Have provided informed consent.
* Underwent case registration by 14 days after the start of administration of drug.

Primary outcomes:
measure: Number of Participants With Hepatic Encephalopathy Risk Factors
timeFrame: Baseline up to 1 year
Secondary outcomes:
measure: Number of Participants with Hepatic Encephalopathy
timeFrame: Baseline up to 1 year
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Eisai trial site 1
city: Tokyo
country: Japan
facility: Eisai trial site 2
Study officials:
References:
Clinical trial NCT03773614: Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries
Official title: Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries - a National Study on Injury Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Injury
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian National Trauma Registry
name: Norwegian National Advisory Unit on Trauma
name: Norwegian Public Roads Administration
name: Norwegian Directorate of Health
name: Norwegian Ministry of Transport and Communications
name: Sykehuset Innlandet HF
First posted: 2018-12-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All trauma patients received by trauma team at any Norwegian trauma hospital during the study period.

Brief summary: Impairing drugs and alcohol are major risk factors for traumatic injuries. Still there is to date little knowledge to what extent these factors affect the epidemiology of trauma. Detailed mapping of risk factors improve targeting and efficiency of primary injury prevention. The aim of this project is therefore to facilitate injury prevention through improved data collection and analysis on impairing drugs and alcohol as a contributing and modifiable factor in injury morbidity and mortality.

Study question: What is the toxicological profile among patients with suspected severe traumatic injury? Study design: a prospective population-based and national observational study will analyse toxicology from blood samples of all trauma admission during a 12 month study period.


Eligibility criteria: Inclusion Criteria:

* admission to any Norwegian Trauma Hospital (n=37) AND trauma team activation, during study period

Exclusion Criteria:

* age
* foreign citizens

Primary outcomes:
measure: Presence of alcohol in blood samples.
timeFrame: Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period. The database is analyzed after study period is completed.
measure: Presence of impairing illicit and medicinal drugs in blood samples.
timeFrame: Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: OsloUH
Study officials:
References:
Clinical trial NCT06915714: The Prognostic Value of PET/CT for Tumor Progression in Patients With Metastatic Hormone-sensitive Prostate Cancer
Official title: The Prognostic Value of Quantitative Parameters Derived From Dual Scanning of FDG and PSMA PET/CT for Tumor Progression in Patients With Metastatic Hormone-sensitive Prostate Cancer Receiving Novel Hormone Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer Metastatic Disease
PET / CT
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 45
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the enrolled patients were Asian(we are a affiliated hospital of a university based in Mainland china ).

Brief summary: Investigators retrospectively collected data from consecutive patients treated at the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, from October 2020 to March 2024. The inclusion criteria were as follows: (1) patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by PSA levels, radiographic tests and pathological information; (2) patients who underwent FDG and PSMA PET/CT prior to the initiation of medical treatment. The exclusion criteria were as follows: (1) patients who received novel hormone therapy or a prostate biopsy prior to PET/CT; (2) patients with other malignancies; (3) patients received hormone therapy without NHT; (4) patients received chemotherapy or radiotherapy prior to or during novel hormone therapy; (5) absence of follow-up data at the hospital.


Eligibility criteria: Inclusion Criteria:

* patients with diagnosis of metastatic hormone-sensitive prostate cancer, confirmed by PSA levels, radiographic tests and pathological information
* patients who underwent FDG and PSMA PET/CT prior to the initiation of medical treatment

Exclusion Criteria:

* patients who received novel hormone therapy or a prostate biopsy prior to PET/CT
* patients with other malignancies
* patients received hormone therapy without novel hormone therapy
* patients received chemotherapy or radiotherapy prior to or during novel hormone therapy
* absence of follow-up data at our institution

Primary outcomes:
measure: Castration-Resistant Prostate Cancer free survival (CRPC-FS)
timeFrame: From date of the initiation of novel hormone therapy until the date of first documented either PSA or radiography-confirmed progression or date of the last follow-up for any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First affiliated hospital, Sun Yat-sen univeristy
state: Guangdong
Study officials:
affiliation: First affiliated hospital, Sun Yat-sen univeristy
name: Fangzheng Xiang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05151614: Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection
Official title: Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19 Pandemic
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study included 2 arms Colchicine group: Colchicine + standard therapy of COVID-19 Control group: Standard therapy of COVID-19

Detailed description: This study will be a randomized controlled trial with 2 arms study trial 1:1 allocation. The sample size was calculated and we need a total of 160 patients (80 Colchicine add on group and 80 controls)

Eligibility criteria: Inclusion Criteria:

* 1. Patients with age above 18 years and of any gender 2. Definite diagnosis of COVID-19 according to the WHO classification criteria 3. Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases 4. Understands and agrees to comply with planned study procedures.

Exclusion Criteria:

1. Patients refuse to enrol in the study
2. Patients with hypersensitivity to colchicine
3. Patients with chronic diseases: Renal failure with eGFR\<30 ml/min; chronic liver disease with hepatic failure (AST/ALT \> 3x normal).; decompensated heart failure, long QT syndrome (QTc \>450 msec.), and uncontrolled arrhythmia; inflammatory bowel disease, chronic diarrhea or malabsorption; pre-existent progressive neuromuscular disease, and Metastatic cancer
4. Pregnancy and breast feeding
5. Medications: immunosuppressive chemotherapy; regular use of digoxin, amiodarone, verapamil or protease inhibitors.

Primary outcomes:
measure: - To assess the percentage of cure of the patients
timeFrame: up to 14 days
measure: - Study the time to recovery
timeFrame: up to 14 days
Secondary outcomes:
measure: - to assess side effects seen during the trial
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad
Study officials:
affiliation: Alnahrin University
name: Ahmed S Abdulamir, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03479814: Adaptive Individualized High-Dose Radiotherapy Analysis-REctum-1 (AIDA-RE-1)
Official title: AIDA-RE-1: Adaptive Individualized Hig-Dose Radiotherapy Analysis-Rectum-1. Interventional Study on Neoadjuvant Adaptive-treatment of High Risk Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Radiotherapy
Neoadjuvant Treatment
Keywords: rectal cancer
neoadjuvant chemoradiation
IMRT-SIB
adaptive radiotherapy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the study is to evaluate achievement of complete pathologic response (pCR) in high-risk rectal cancer treated with neoadjuvant concomitant chemotherapy plus adaptive-intensity modulated imaging-guided radiotherapy

Detailed description: AIDA-RE-1 is an interventional prospective trial for the treatment of locally advanced high-risk rectal cancer. In neoadjuvant setting, patients are treated with standard chemotherapy plus experimental radiotherapy. The total dose to clinical target volume (CTV, rectum and locoregional lymph nodes) is 45 Gy, with a concomitant boost of 5 Gy to gross tumor volume (GTV), delivered with IMRT-SIB (intensity modulated radiotherapy-simultaneous integrated boost) technique in 25 fractions. After 2 weeks of treatment, patients are evaluated with 18 FDG-PET and sequential boost of 5 Gy (in 2 fractions) is planned.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed diagnosis of locally advanced rectal cancer (cT3N+, cT4Nx, local relapse, cT3N0); cT2N+ is acceptable if low rectum is involved
* M0
* ECOG 0-2

Exclusion Criteria:

* M1
* familial adenomatous polyposis (FAP), non-polyposis hereditary colorectal cancer, inflammatory bowel disease
* severe cardiopathy
* previous pelvic RT

Primary outcomes:
measure: complete pathological response (pCR)
timeFrame: 6 weeks
Secondary outcomes:
measure: Acute toxicity
timeFrame: 6 months
measure: Quality of Life (QoL)
timeFrame: 1 year
measure: Late toxicity
timeFrame: 1 year
measure: Dosimetric advantage of GTV-boost reduction
timeFrame: 6 weeks
measure: Evaluation of PET-response as predictive factor
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
state: BO
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References: