louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02366351: The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Type 2 Diabetes Mellitus Patients
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Clinical Trial to Evaluate the Pharmacokinetics/Pharmacodynamics, Efficacy and Safety of SHR3824 as Monotherapy in Chinese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 168
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: The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824 over 12 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the effect of SHR3824 to placebo when given in oral doses.


Eligibility criteria: Inclusion Criteria:

* Patients must have a diagnosis of type 2 diabetes mellitus;
* Hemoglobin A1c levels \>=7.5% and \<=10.5%;
* Body mass index (BMI) 25 to 45 kg/m2;
* Patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.

Exclusion Criteria:

* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
* Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
* Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
* History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
* Past or current history of malignant tumor;
* Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
* Pregnant women, lactating mothers, or women of childbearing potential;
* Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).

Primary outcomes:
measure: Adjusted Mean Change in HbA1c Levels
timeFrame: Baseline to Week 12
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Adjusted Mean Change in Fasting Plasma Glucose
timeFrame: Baseline to Week 12
measure: Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References:
Clinical trial NCT06311851: Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases
Official title: An Open-Label Pilot Study to Evaluate Efficacy and Safety of Bevacizumab Via Transarterial Chemoembolization (TACE) in Patients With Liver Metastases
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Cancer
Metastatic Cancer
Liver Metastases
Lead sponsor: Pardis Noor Medical Imaging and Cancer Center
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Trans arterial chemoembolization (TACE) has emerged as a treatment option for chemotherapy-refractory diseases in Liver metastases. By delivering chemotherapy agents directly to the tumor site, TACE can maximize local drug concentrations and reduce systemic adverse reactions. Bevacizumab is a monoclonal antibody that functions as an angiogenesis inhibitor. It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A). The application of Bevacizumab during TACE has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy, and safety of the application of Bevacizumab during TACE in patients with Liver Metastases by designing an open, single-arm phase II clinical study.


Eligibility criteria: Inclusion Criteria:

* Confirmation of metastatic liver cancer via histological examination or a characteristic imaging profile on dynamic computed tomography (CT) scan or magnetic resonance imaging (MRI) without indications for surgical resection
* Eastern cooperative oncology group performance status (ECOGPS) of 0 or 1
* Liver function categorized as Child-Pugh class A or B
* Stable non-hepatic metastases, such as skeletal, pulmonary, or lymph node metastases
* Hepatic tumor burden below 70%
* Expected survival duration exceeding six months
* Laboratory findings meeting specific criteria, including platelet count \>50×109 /L, hemoglobin \>8.0 g/dL, ANC count ≥1.5 × 109/L, bilirubin \<51 mmol/L, alanine and aspartate aminotransferase \<3 times the upper limit of the normal range, and serum creatinine \<1.5 times the upper limit of the normal range.

Exclusion Criteria:

* Active infection
* Presence of severe comorbidities, such as hepatic encephalopathy, refractory ascites, and esophageal variceal bleeding
* Prior liver resection
* Previous TACE therapy received at other healthcare facilities
* Poor performance status (ECOGPS \> 1)

Primary outcomes:
measure: Overall Survival Rate
timeFrame: 6 months
measure: Objective response rate
timeFrame: 6 months
Secondary outcomes:
measure: Adverse event
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Pardis Noor Medical Imaging and Cancer Center
Study officials:
References:
Clinical trial NCT06408051: Efficacy of 200 IU OnabotulinumtoxinA in Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment
Official title: Efficacy of 200 IU OnabotulinumtoxinA (Botulinum Toxin Type A) in Patients With Idiopathic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment
Lead sponsor: Hisar Intercontinental Hospital
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In patients with overactive bladder and urinary incontinence who had previously failed to respond to anticholinergic treatments

Brief summary: This study aimed to assess the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) in patients with idiopathic overactive bladder (OAB) and urinary incontinence who had previously failed to respond to anticholinergic treatment. Additionally, we examined the impact of significant reductions in bladder wall thickness on therapeutic outcomes.

Detailed description: The efficacy of OnabotulinumtoxinA was investigated in patients who attended urology outpatient clinics between January 2016 and June 2022 for overactive bladder unresponsive to anticholinergic therapy. Baseline symptoms and quality of life data were compared to those at month 6 after the treatment. The voiding diary (for 3 days) of each patient was reviewed to assess and record patients' symptoms. Baseline ultrasound (US)-measured post-void residual urine (PVR) and bladder wall thickness (BWT) values were recorded. Patients with a history of neurological disorders, anticholinergic-naive patients, patients diagnosed with bladder cancer, and those with bladder outlet obstruction were excluded from the study.

Eligibility criteria: Inclusion Criteria:

* overactive bladder urge incontinence

Exclusion Criteria:

* neurological and/or neurosurgical disorders, anticholinergic-naive patients, bladder cancer, bladder stone, interstitial cystitis, prostate cancer chronic prostatitis bladder outlet obstruction

Primary outcomes:
measure: frequencies of urination, nocturia, incontinence episodes
timeFrame: 1 years
measure: urgency,
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basri Cakiroglu
city: Istanbul
country: Turkey
facility: Hisar Intercontinental Hospital
Study officials:
References:
Clinical trial NCT05764551: The Application of Serum DNA Methylation for Patients With HCC
Official title: he Application of DNA Methylation for Patients Who Had Hepatocellular Carcinoma With Normal Serum Alpha-fetoprotein
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: DNA methylation
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this single-arm prospective study is to evaluate the application of serum DNA methylation for HCC patients with normal alpha-fetoprotein. The main question it aims to answer is

. Is the dynamic change of serum DNA methylation correlated to recurrence or treatment response of HCC

Detailed description: The enrolled individuals with HCC and normal serum alpha-fetoprotein level would receive serum DNA methylation test before their treatment (including all kinds of recommened HCC treatment). Then regularly serum DNA methylation test would be done at 4th\~8th weeks, 16th week, 32th week and 48th week. If the enrolled patients did not have HCC recurrence during at 48th week. The regular check of serum DNA methylation would be canceled. The enrolled patients would be observed till 96th week. If there is any recurrence during 48\~96th week, one time of serum DNA methylation would be checked at the time of recurrence. The observation and intervention would be completed at 96th week.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 years old
* The diagnosis of hepatocellular carcinoma (HCC) according to AASLD 2018 clinical guidelines or histology report
* Individuals with HCC and normal serum alpha-fetorpotein level (\<20 ng/ml)
* Individuals who could sign informed consent

Exclusion Criteria:

* The histology report revealed non-HCC, HCC mixed with cholangiocarcinoma or sarcomatoid HCC
* Individuals with HCC and other concurrent malignancies
* Individuals with chronic kidney disease who could not tolerate contrast-enhanced dynamic images
* Individuals ever receiving any organ transplantation
* Individuals with HIV infection
* Individuals who could not able to understand and sign informed consent

Primary outcomes:
measure: The correlation between serum DNA methylation and HCC recurrence or treatment response
timeFrame: 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Ditmanson Medical Foundation Chiayi Christian Hospital
Study officials:
affiliation: Ditmanson Medical Foundation Chiayi Christian Hospital
name: Po-Yueh Chen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04381351: Noncoding RNAs in COVID-19 and COVID-19 Related Kidney Dysfunction
Official title: The Role of Noncoding RNAs in COVID-19 and COVID-19 Associated Acute Kidney Injury (MiRCOVID)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: acute kidney injury (AKI)
organ dysfunction
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients with critical illness on ICU.

Brief summary: In this study, critically ill patients with highly suspected or confirmed COVID-19 will be included. Main goal is the identification of noncoding RNAs in COVID-19 associated organ dysfunction with an emphasis on acute kidney injury.


Eligibility criteria: Inclusion Criteria:

* COVID-19

Exclusion Criteria:

* kidney transplantation
* eGFR \< 30 ml/Min
* dialysis within last 90 days
* chronic dialysis
* pregnancy

Primary outcomes:
measure: predicitive value of noncoding RNAs in COVID-19 associated organ dysfunction
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Klinik für Anästhesiologie
Study officials:
References:
Clinical trial NCT00602251: Bioequivalency Study of Terbinafine Tablets Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 250 mg Terbinafine Hydrochloride Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to terbinafine or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Twenty-one day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Gateway Medical Research, Inc.
state: Missouri
Study officials:
affiliation: Cetero Research, San Antonio
name: Steven Herrmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01551251: Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer
Official title: Tumor-Associated Macrophages Correlate With Response and Outcomes in Advanced Non-Small Cell Lung Cancer After First Line Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Nonsmall Cell Lung Cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with advanced non-small cell lung cancer (stage IIIb and IV NSCLC) who had been treated at the Linkou Branch of Chang Gung Memorial Hospital between 2006 and 2009 were included.

Brief summary: The purpose of this study is to investigate the effects of tumor associated macrophage (TAM) in advanced non-small cell lung cancer (NSCLC) patients on the treatment response and outcome of these subjects. Pathologic specimens from tissue bank will be stained by immunostaining methods with CD68 antibody. The clinical treatment response and outcomes will be analyzed between high or low TAM.


Eligibility criteria: Inclusion Criteria:

* advanced NSCLC,
* more than 20 years old,
* measurable tumor,
* response and outcome recorded after the first line treatment.

Exclusion Criteria:

* Early stage NSCLC,
* less than 20 years,
* pregnancy,
* unmeasurable NSCLC.

Primary outcomes:
measure: Response to treatment of advanced NSCLC with high or low TAM.
timeFrame: 2-3 months
Secondary outcomes:
measure: Outcomes of advanced NSCLC with high and low TAM.
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Sant Paul Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Fu-Tsai Chung, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen JJ, Lin YC, Yao PL, Yuan A, Chen HY, Shun CT, Tsai MF, Chen CH, Yang PC. Tumor-associated macrophages: the double-edged sword in cancer progression. J Clin Oncol. 2005 Feb 10;23(5):953-64. doi: 10.1200/JCO.2005.12.172. Epub 2004 Dec 14.
Clinical trial NCT03226951: SDM Laser for Non Central Diabetic CSME
Official title: Sub Threshold Laser for Non Central Diabetic Clinical Significant Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Central Diabetic Macular Edema
Lead sponsor: Marashi Eye Clinic
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Is to determine if SDM laser can reduce macular thickness in non central CSME and stop the progression of non central CSME to central CSME in compare to glycemic control

Detailed description: interventional randomised masked study will recruit patients have diabetes mellitus with non central CSME with good vision into two groups : 1st SDM laser with glycemic control 2nd SHAM laser with Glycemic control where BCVA will be recorded every month starting from baseline to 24 weeks where OCT will be recorded every 8 weeks from baseline to 24 weeks

Eligibility criteria: Inclusion Criteria:

* Patients with central diabetic macular edema Best corrected visual acuity is 20/30 or more
* Non central Macular thickness more than 250 microns
* Patients who are able to come for all follow-up

Exclusion Criteria:

* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
* Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
* For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
* Macular edema is present that is considered to be related to ocular surgery such as cataract extraction
* Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
* History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
* Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis

Primary outcomes:
measure: Number of eyes with reduced macular thickness
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of eyes with reduced vision
timeFrame: 24 weeks
measure: Number of eyes developing central macular edema
timeFrame: 24 weeks
measure: Number of patients achieved good glycemic control
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Marashi Eye Clinic
Study officials:
References:
citation: Marashi A. Non-central diabetic clinical significant macular edema treatment with 532nm sub threshold laser. Adv Ophthalmol Vis Syst. 2018;8(3):151-154. DOI: 10.15406/aovs.2018.08.0029
Clinical trial NCT02335151: CTC Pancreatic Adenocarcinoma
Official title: Resectable Pancreatic Adenocarcinoma - Does the Type of Anesthesia Have an Impact on Circulating Tumor Cells?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adenocarcinoma
Circulating Tumor Cells
Pancreatic Neoplasms
Keywords: Circulating Tumor Cells
Anesthesia and immunity
Cell Search System
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Kantonsspital Winterthur KSW
name: Triemli Hospital
name: Cantonal Hospital of St. Gallen
First posted: 2015-01-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor removal of pancreatic cancer will be determined and correlated to the accordance of anesthesia (desflurane versus propofol)

Detailed description: This prospective, randomized study will be conducted over a 36-month period to investigate whether commonly used anesthetics (volatile versus intravenous) have an effect on the changes or occurrence of CTC in patients suffering from primary pancreatic cancer undergoing curative surgery. The specific research question is if there are changes of the CTC count in the postoperative phase in the desflurane group (intervention) compared to the propofol one (control). A secondary question is if these changes can be correlated to tumor outcome.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 85
* ASA I-III ( American Society of Anesthesiologists)
* Resectable pancreatic adenocarcinoma
* Primary surgery
* No neoadjuvant therapy
* Written informed consent

Exclusion Criteria:

* Metastatic disease
* Other than primary surgery (recurrence, reconstruction)
* Pre-operative chemotherapy
* Chronic opioid use
* Known hypersensitivity or suspected allergy to propofol, soya or egg proteins
* Known hypersensitivity to volatile anaesthetics (malignant hyperthermia)
* Pregnancy
* Breast feeding
* Enrolment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion

Primary outcomes:
measure: Peak of CTC in the postoperative phase after curative tumor removal
timeFrame: Day 0 to Day 7
Secondary outcomes:
measure: Kinetics of CTC after surgery up to day 7
timeFrame: 1 year
measure: Month to Tumor recurrence
timeFrame: 1 year
measure: Number of surviving patients
timeFrame: 1 year
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: University of Zurich
name: Beatrice Beck Schimmer, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: