louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01393665: Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease
Official title: Multicenter, Randomized, Placebo-Controlled, Double-blind Phase 2 Study to Evaluate the Short-term Efficacy, Safety and Tolerance and to Find an Optimal Dosage of the PENNEL Capsule for the Patients With Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Liver Disease
Lead sponsor: PharmaKing
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic oil. The two components were confirmed to have complementary effects because of different operational mechanism in animal experiments, and were examined on humans in this study. Both BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity caused by toxic substances, and the purpose of this study is to confirm efficacy of and safety on human body of the agent and to determine its optimal dose.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic liver disease.
* Patients over 20, under 65 years of age.
* Patients with abnormal transaminase levels.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients who have any history of esophageal bleeding, hepatic encephalopathy, ascites.
* Diabetes, thyroid dysfunction, fatty liver, liver cancer patients.
* Toxic hepatitis, alcoholic hepatitis.
* Total bilirubin value more than 3.0 mg/dl.
* Albumin value less than 3.0 g/dl.
* Patients who participating in other study about drug.

Primary outcomes:
measure: ALT (Alanine Aminotransferase)
timeFrame: 6 week
Secondary outcomes:
measure: AST (Aspartate Aminotransferase)
timeFrame: 6 weeks
measure: g-GT (γ-glutamyl transpeptidase)
timeFrame: 6 weeks
measure: Total bilirubin
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
state: Nowon-gu
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
state: Seongdong-gu
Study officials:
affiliation: Hanyang University
name: Minho Lee, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee MH, Kim YM, Kim SG. Efficacy and tolerability of diphenyl-dimethyl-dicarboxylate plus garlic oil in patients with chronic hepatitis. Int J Clin Pharmacol Ther. 2012 Nov;50(11):778-86. doi: 10.5414/CP201746.
Clinical trial NCT00531765: Sodium Bicarbonate in Preventing Contrast Induced Nephropathy
Official title: Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN): A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast Induced Nephropathy
Keywords: contrast-induced-nephropathy,
cardiac cath
creatinine
contrast
nephropathy
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-09-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion.

Detailed description: We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion. 220 adult patients scheduled for routine cardiac catheterization will be enrolled. They will stratified according to the presence or absence of DM, or an estimated GER of less than 60 ml/hr before being block-randomized to the two groups. The incidence of CIN will be determined based on the average of two measurements of creatinine level before and 48 hours after the procedure, and an increase of 25% or 0.5 mg/dL (44.2 umol/L) or more.

Eligibility criteria: Inclusion Criteria:

All adult patients (18 years and above) who are scheduled for cardiac catechization and have abnormal but stable renal function will be eligible for enrollment. Abnormal renal function is defined as a creatinine level exceeding the normal range (more than 115 or 96 um/L in males and females, respectively, in KFSH\&RC laboratories) or eGFR less than 60 ml/min

Exclusion Criteria:

Patients who fall under any of the following categories will be excluded:

* Acute renal failure
* Cardiogenic shock
* Emergency cardiac catheterization
* Preexisting peritoneal or hemodialysis
* Pregnancy
* Recent exposure to contrast agent within the last 3 days
* Allergy to contrast or any of the above treatment
* Renal transplant,
* Patients who received dopamine, mannitol, theophyllin or other medications known to affect renal function within one week from cardiac cath
* Pulmonary edema / congestive heart failure
* Use of N-acetylcystein
* Patents on NSAIDS who can not stop using them for 48 hrs before and 48 hrs after procedure (except Aspirin).

Primary outcomes:
measure: Incidence of Contrast Induced nephropathy
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Fawaz Al Turki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06802965: Shanghai Atrial Fibrillation Registry
Official title: Shanghai Atrial Fibrillation Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Atrial Fibrillation (AF)
Keywords: atrial fibrillation
left atrial appendage closure
catheter ablation
risk score
Chinese
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Health Statistics Center
First posted: 2025-01-31
Enrollment: 400000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population include patients with a diagnosis of AF in the Shanghai Municipal Health Commission database who are residence of Shanghai and with government-issued health insurance.

Brief summary: Using the Shanghai Municipal Health Commission database and Shanghai Centers for Disease Control and Prevention database, patients with AF in Shanghai are included to construct the Shanghai AF registry to investigate clinical characteristics, treatment, and prognosis.

Detailed description: 1. To determine the most suitable risk stratification model for Chinese AF population regarding stroke and major cardiovascular events, i.e. CHA2DS2-VASc, CHA2DS2-VASc-60, or CHA2DS2-VA scores.
2. To compare the clinical prognosis of patients with AF receiving the combined procedure of catheter ablation and left atrial appendage closure (LAAC), single catheter ablation, and single LAAC.

Eligibility criteria: Inclusion Criteria:

* With diagnosis of AF: the diagnosis must be identified from the Shanghai Municipal Health Commission database and verified by 12-lead ECG or Holter monitoring since 2015
* Residents of Shanghai
* Taking part in the government-issued health insurance, including the Urban Residents' Basic Medical Insurance (URBMI), the Urban-Employ Based Medical Insurance (UEBMI) and the New Rural Cooperative Medical Scheme (NRCMS).

Exclusion Criteria:

* Non-residence of Shanghai
* Without the government-issued health insurance
* Die at the day of index diagnosis of AF

Primary outcomes:
measure: Composite of death, ischemic stroke, systemic embolism, myocardial infarction, major bleeding, and acute heart failure
timeFrame: From enrollment to December 31, 2024
Secondary outcomes:
measure: Cardiovascular death
timeFrame: From enrollment to December 31, 2024
measure: Non-cardiovascular death
timeFrame: From enrollment to December 31, 2024
measure: Ischemic stroke
timeFrame: From enrollment to December 31, 2024
measure: Systemic embolism
timeFrame: From enrollment to December 31, 2024
measure: Myocardial infarction
timeFrame: From enrollment to December 31, 2024
measure: Major bleeding
timeFrame: From enrollment to December 31, 2024
measure: Acute Heart failure (HF)
timeFrame: From enrollment to December 31, 2024
Other outcomes:
measure: Medical cost
timeFrame: From enrollment to December 31, 2024
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
References:
Clinical trial NCT02014220: The Food Intake, Satiety and Blood Glucose After Ingestion of Potato Chips Produced From Three Potato Cultivars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Diabetes
Metabolic Syndrome
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2013-12-18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: Potato is one of the world's most popular foods and is widely accepted as a staple food. The objective of this study is to determine the effect of consuming potato chips from different cultivars on blood glucose, subjective appetite and food intake. It is hypothesized that the chips produced from various potato cultivars will differ in their effect on blood glucose, satiety and food intake.


Eligibility criteria: Inclusion Criteria:

* Healthy men with a body mass index (kg/m2) of 20-24.9

Exclusion Criteria:

* smocking, medication, breakfast skipping, restrained eating

Primary outcomes:
measure: blood glucose
timeFrame: 120 min
Secondary outcomes:
measure: food intake
timeFrame: 120 min
Other outcomes:
measure: satiety
timeFrame: 120 min
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences
state: Ontario
Study officials:
References:
Clinical trial NCT01784120: A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
Official title: A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: breast cancer
doxorubicin
genexol-PM
paclitaxel
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer

1. Primary Purpose: response rate
2. Secondary purpose: toxicity, progression-free survival, overall survival


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older adult women
* Instrumentation measurable lesions with histologically confirmed advanced (recurrent or metastatic) breast cancer
* ECOG 0-2
* Advanced breast cancer in the past, patients who did not receive chemotherapy
* Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more than 6 months until the patient
* life expectancy more than 3 months
* Agree in writing before the party to participate in a clinical trial to patients

Exclusion Criteria:

* immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients
* Severe infections requiring antibiotic therapy
* Clinically significant heart disease
* Pregnant or lactating woman
* Uncontrolled symptoms in the central nervous system (CNS) metastases
* Patients diagnosed with malignant tumors of other organs

Primary outcomes:
measure: response rate
timeFrame: one year
Secondary outcomes:
measure: number of participants with adverse events
timeFrame: one year
Other outcomes:
measure: overall survival
timeFrame: one year
measure: progression-free-survival
timeFrame: one year
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
References:
Clinical trial NCT00750620: A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
Official title: A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Effect of Mild, Moderate and Severe Renal Impairment on the Pharmacokinetics of YM178
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: mild, moderate, and severe renal impaired subjects
normal renal function subjects
Glomerular filtration rate (GFR)
Modification of Diet in Renal Disease (MDRD) formula
YM178
pharmacokinetics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.


Eligibility criteria: Inclusion Criteria:

* good health other than renal impairment
* body mass index (BMI) between 18 and 40 kg/m2

Exclusion Criteria:

* subject with renal impairment has not been on stable dose of concomitant medication for at least 2 weeks
* subject has liver enzyme abnormalities

Primary outcomes:
measure: Assessment of pharmacokinetics parameters
timeFrame: day 1 - day 6
Secondary outcomes:
measure: Metabolite analysis
timeFrame: day 1 - day 6
measure: Assessment of safety and tolerability
timeFrame: day 1 - day 6
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Astellas Pharma Global Development
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: Dickinson J, Lewand M, Sawamoto T, Krauwinkel W, Schaddelee M, Keirns J, Kerbusch V, Moy S, Meijer J, Kowalski D, Morton R, Lasseter K, Riff D, Kupcova V, van Gelderen M. Effect of renal or hepatic impairment on the pharmacokinetics of mirabegron. Clin Drug Investig. 2013 Jan;33(1):11-23. doi: 10.1007/s40261-012-0031-3.
Clinical trial NCT01665820: Auscultate Obese Patients Using Electronic and Traditional Stethoscopes
Official title: Study EM-05-012530 Benefit of Auscultation With 3M™ Littmann® 3200 Electronic Stethoscope to Diagnose Murmurs and Heart Pathologies in Overweight and Obese Patients With Increased Layers of Adipose Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pathology
Keywords: chest
pathology
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2012-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients greater or equal to 18 years of age, with a BMI greater than 30 and who have been scheduled for an echocadiogram examination

Brief summary: Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more effective in identifying referrable murmurs than using a traditional stethoscope.

Detailed description: Study will enroll subjects who have greater than 30 BMI ratings. Each subject will receive 4 auscultation examinations. Two auscultations will be done by a cardiologist using both an acoustic traditional stethoscope and an electronic stethoscope. Two additional auscultations will be done by a 3rd year medical resident also using both an acoustic traditional stethoscope and an electronic stethoscope. All determinations will be compared to echocardiography results.

Eligibility criteria: Inclusion Criteria:

* Greater or equal than 18 years of age
* Referred for an echocardiogram
* obese, as defined as having a BMI greater than 30
* volunteers to participate in study
* agrees to provide copy of echocardiogram exam report

Exclusion Criteria:

-Investigator believes subject should not be included or is unsuitable for inclusion

Primary outcomes:
measure: Most severe cardiac lesion identified by auscultation & echocardiography
timeFrame: 0-4 days
Secondary outcomes:
measure: Secondary cardiac lesion identified by auscultation & echocardiography
timeFrame: 0 - 4 days
measure: Other heart sounds identified by auscultation & echocardiography
timeFrame: 0 - 4 days
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Egle Kalinauskiene, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05823220: A Pragmatic Trial Integrating Homelessness Diversion Services Into an Emergency Department Discharge System
Official title: A Pragmatic Randomized Trial Integrating Homelessness Diversion Services Into an Emergency Department Discharge System
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Homelessness
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-04-21
Enrollment: 1000
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 purpose of this study is to determine whether a homelessness diversion program integrated into a hospital emergency department (ED) will lower ED use, to identify characteristics of individuals most likely to benefit from homelessness diversion and to discover opportunities to tailor Homelessness Diversion (HD) services to better meet the needs of diverse communities.


Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* discharged from a Harris Health Hospital ED (Ben Taub or LBJ)
* at imminent risk of homelessness
* patients with Medicaid, Medicare or who are uninsured

Exclusion Criteria:

* having a conservator (legal guardian)
* plans to move away from Texas in 6 months

Primary outcomes:
measure: Number of ED visits
timeFrame: end of study (6 months after start of study)
Secondary outcomes:
measure: Number of participants who experience homelessness
timeFrame: end of study (6 months after start of study)
measure: Change in health related quality of life as assessed by the Short Form-12 version 2.0 (SF12v2) health Survey
timeFrame: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jack Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00893620: Zenith(R) Connection Endovascular Covered Stent Clinical Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aorto-iliac Aneurysms
Iliac Aneurysms
Keywords: iliac aneurysm
endovascular repair
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2009-05-06
Enrollment: 1
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: The Zenith(R) Connection Endovascular Covered Stent Clinical Study is a clinical investigation to study the safety and performance of the Zenith(R) Connection Endovascular Covered Stent in conjunction with the Zenith(R) Branch Endovascular Graft-Iliac Bifurcation in the treatment of aorto-iliac and iliac aneurysms.


Eligibility criteria: Inclusion Criteria:

* An aortoiliac or iliac aneurysm of appropriate size
* Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery

Exclusion Criteria:

* Less than 18 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Unsuitable arterial anatomy

Primary outcomes:
measure: Deployment and procedural outcome
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lingen
country: Germany
facility: St. Bonifatius Hospital GmbH
city: Muenster
country: Germany
facility: St. Franziskus Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
affiliation: Christine E. Lynn Heart and Vascular Institute
name: Anthony Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06715020: Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging
Official title: Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Yunnan Cancer Hospital
First posted: 2024-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to construct a noninvasive approach 68Ga-TTP PET/CT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.


Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);
2. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 /L, PLT ≥ 100×109/L, Hb≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;
3. Patients with confirmed or suspected breast cancer;
4. Expected survival ≥12 weeks;
5. Good follow-up compliance;
6. Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;
7. Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.

Exclusion Criteria:

1. Severe abnormal liver and kidney function;
2. Pregnant, pregnant and lactating women;
3. Can not lie flat for half an hour;
4. Unable to obtain informed consent;
5. Suffering from claustrophobia or other mental illness;
6. People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;
7. Other conditions deemed unsuitable for participation in the trial by the investigator.

Primary outcomes:
measure: Standardized uptake value（SUV）
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: