louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04215211: MR Based Survival Prediction of Glioma Patients Using Artificial Intelligence
Official title: MR Based Survival Prediction of Patients With Primary Glioma Ssing Deep Learning or Machine Learning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma
Keywords: Prognosis
Radiomics
Deep Learning
Machine Learning
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2020-01-02
Enrollment: 2500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Paitents with newly diagnosed glioma who receive tumor resection with life expectancy of greater than 3 months

Brief summary: This registry aims to collect clinical, molecular and radiologic data including detailed survival data, clinical parameters, molecular pathology (1p/19q codeletion, MGMT methylation, IDH and TERTp mutations, etc) and conventional/advanced/new MR sequences (T1, T1c, T2, FLAIR, ADC, DTI, PWI, etc) of patients with primary gliomas. By leveraging artificial intelligence, this registry will seek to construct and refine algorithms that able to predict patients' survivals in the frame of molecular pathology or subgroups of gliomas.

Detailed description: Non-invasive and precise prediction for survivals of glioma patients is challenging. With the development of artificial intelligence, much more potential lies in the preoperative conventional/advanced MR imaging (T1 weighted imaging, T2 weighted imaging, FLAIR, contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, and perfusion imaging) could be excavated to aid prediction of patients' prognosis in the frame of molecular pathology of gliomas. The creation of a registry for primary glioma with detailed survival data, molecular pathology, radiological data and with sufficient sample size for deep learning (\>1000) provides opportunities for personalized prediction of survival of glioma patients with non-invasiveness and precision.

Eligibility criteria: Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of primary glioma
* Life expectancy of greater than 3 months
* Must receive tumor resection
* Signed informed consent

Exclusion Criteria:

* No gliomas
* No sufficient amount of tumor tissues for detection of molecular pathology
* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic devices
* Patients who are pregnant or breast feeding
* Patients who are suffered from severe systematic malfuctions

Primary outcomes:
measure: AUC of survival prediction performance
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT00051493: ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.
Official title: ALIMTA Plus Carboplatin as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small Cell Lung Cancer
Lung Cancer
NSCLC
Advanced Non-Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2003-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects (good and bad) of LY231514 (ALIMTA) and Carboplatin on you and your non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* You have a diagnosis of non-small cell lung cancer.
* You have received no prior chemotherapy.
* You have at least one measurable lesion.
* You have an adequate performance status.
* You are at least 18 years of age.

Exclusion Criteria:

* You have previously received chemotherapy for your lung cancer.
* You have received radiation within the last 30 days.
* You have active infection or other serious condition.
* You have brain metastasis.
* You have recently lost a significant amount of weight.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT04048993: Registry-based Biobank Development and Integrative Physiological Analysis
Official title: Registry-based Biobank Development and Integrative Physiological Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Integrative Human Physiology
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Human subjects able to perform exercise

Brief summary: The purpose is to develop a registry-based biobank for integrative physiological analysis based on biological samples (blood, urine, interstitial fluid and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters


Eligibility criteria: Inclusion Criteria:

* able to perform fatiguing exercise

Exclusion Criteria:

* severe mental or physical handicap
* chronic disease deemed by the M.D. to preclude inclusion
* use of prescription medicine deemed by the M.D. to preclude inclusion

Primary outcomes:
measure: Biobank creation
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
References:
Clinical trial NCT01465893: Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography
Official title: The Investigation Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Optic Neuritis
Keywords: vitamin d
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the effect of vitamin D on Retinal changes in patient with optic Neuritis.


Eligibility criteria: Inclusion Criteria:

* age 15-50 years
* no history of demyelinative events
* level of vitamin d below 20 ng/ml
* no pass 10-32 day from starting symptom

Exclusion Criteria:

* using vitamin D supplement

Primary outcomes:
measure: measurement Retinal nerve fiber layer (RNFL) thickness by OCT
timeFrame: 10-32 days after optic neuritis
Secondary outcomes:
measure: measurement RNFL thickness by OCT
timeFrame: 6 months after optic neuritis
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Isfahan Medical University
Study officials:
References:
citation: Salari M, Janghorbani M, Etemadifar M, Dehghani A, Razmjoo H, Naderian G. Effects of vitamin D on retinal nerve fiber layer in vitamin D deficient patients with optic neuritis: Preliminary findings of a randomized, placebo-controlled trial. J Res Med Sci. 2015 Apr;20(4):372-8.
Clinical trial NCT01017393: Preemptive Low-dose Epidural Ketamine for Preventing Chronic Post-thoracotomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Post-thoracotomy Pain
Keywords: preemptive epidural ketamine
prevention of chronic post-thoracotomy pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 209
Sex: ALL
Minimum age (years): 19
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. While thoracic epidural analgesia has become the mainstay for managing acute post-thoracotomy pain, its effect on the chronic post-thoracotomy pain seems questionable. The objective of this prospective, double-blinded, randomized, controlled trial was to assess the effect of preemptive low-dose epidural ketamine in addition to preemptive thoracic epidural analgesia on the incidence of chronic post-thoracotomy pain.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery with a thoracotomy incision

Exclusion Criteria:

* history of previous thoracic surgery, chronic pain, psychiatric disease, cardiac or vascular disease, neurologic deficits, or contraindications to epidural catheterization such as coagulopathy, or localized or systemic infection

Primary outcomes:
measure: Incidence of pain 3 months after surgery
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06671093: Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Official title: Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Hep B
Chronic Hepatitis b
Chronic Hepatitis
HBV
Keywords: Tune-401
Tune-401-001
CHB
Lead sponsor: Tune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.

Detailed description: This study consists of an open-label, single-ascending dose phase, which will identify the dose for evaluation in a cohort expansion. The expansion phase will be open-label to further characterize the activity of Tune-401 on PD parameters and obtain additional safety data.

Eligibility criteria: Inclusion Criteria:

* M/F age 18-75, inclusive
* Diagnosed with Chronic Hepatitis B
* On nucleos(t)ide analogue
* HBeAg-negative or positive
* HBsAg \> 500 IU/ml
* HBV DNA \< 90 IU/ml

Exclusion Criteria:

* ALT/ AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥ 1. 5 × ULN
* Participants with any evidence or history of liver disease of non-HBV etiology
* Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Safety as assessed by treatment emergent adverse events
timeFrame: 20 weeks
Secondary outcomes:
measure: Long-term safety
timeFrame: 104 weeks
measure: Tune-401 Pharmacokinetics (Cmax)
timeFrame: 8 weeks
measure: Tune-401 Pharmacokinetics (Tmax)
timeFrame: 8 weeks
measure: Tune-401 Pharmacokinetics (AUC)
timeFrame: 8 weeks
measure: Tune-401 Pharmacokinetics (CL)
timeFrame: 8 weeks
measure: Tune-401 Pharmacokinetics (half-life)
timeFrame: 8 weeks
measure: Tune-401 Pharmacokinetics (Vd)
timeFrame: 8 weeks
measure: Tune-401 Pharmacodynamics
timeFrame: 104 weeks
measure: Tune-401 Immunogenicity
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, University of Hong Kong
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research
Study officials:
References:
Clinical trial NCT01559493: Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)
Official title: Comparison of Fractional Flow Reserve Versus Instant Wave-Free Ratio for Assessment of Coronary Artery Stenosis Severity in Routine Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Plaque, Atherosclerotic
Keywords: atherosclerotic lesion assessment
Lead sponsor: NHS National Waiting Times Centre Board
Sponsor class: OTHER
Collaborators: name: Golden Jubilee National Hospital
name: Catharina Ziekenhuis Eindhoven
name: Onze Lieve Vrouw Hospital
name: Stockholm South General Hospital
name: Brno University Hospital
name: Stanford University
First posted: 2012-03-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim of the present study is to strengthen the results of retrospective comparisons of iFR with FFR by conducting a prospective study in 200 consecutive, unselected patients from 5 different centers.

Brief summary: Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice

* To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI).
* To investigate the influence of hyperemia on iFR.
* To test reproducibility of iFR and FFR.


Eligibility criteria: Inclusion Criteria:

* all consecutive patients undergoing FFR assessment for standard clinical indications.

Exclusion Criteria:

* prior CABG
* extremely tortuous, calcified lesions
* coronary artery occlusion
* acute MI within 5 days

Primary outcomes:
measure: Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice
timeFrame: 30 days
Secondary outcomes:
measure: iFR at rest vs iFr during hyperemia
timeFrame: 30 days
measure: Repeatability of iFr and FFR
timeFrame: 30 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aalst
country: Belgium
facility: Cardiovascular Center Aalst
city: Brno
country: Czech Republic
facility: University Hospital Brno
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Stockholm
country: Sweden
facility: Stockholm South Hospital
Study officials:
affiliation: Golden Jubilee National Hospital
name: Prof Keith G. Oldroyd
role: PRINCIPAL_INVESTIGATOR
affiliation: Golden Jubilee National Hospital
name: Prof Colin Berry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.
Clinical trial NCT00345293: Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer
Official title: A Phase I/II Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2006-06-28
Enrollment: 13
Sex: MALE
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 purpose of this study is to assess the safety and activity of DC/PC3, a dendritic cell vaccine used as immunotherapy for prostate cancer. The vaccine is made with each participants' own immune cells obtained through blood donation. Dendritic cells are known to activate other immune cells such as T cells, that are able to mount an attack against cancer cells. The dendritic cell vaccine will be administered as injections every 2 weeks over a course of 2 months.

Detailed description: See Brief Summary.

Eligibility criteria: Inclusion Criteria:

Prostate cancer

Rising prostate specific antigen (PSA, 3 values, each measured at least 2 weeks apart) post initial therapy (ie, radiation, prostatectomy) human leukocyte antigen A2.1 (HLA-A2.1)

-

Exclusion Criteria:

central nervous system metastasis

History of autoimmune disease

Primary outcomes:
measure: Toxicity
timeFrame: through week 29
Secondary outcomes:
measure: Immunogenicity
timeFrame: pre and post treatment
measure: Clinical Response
timeFrame: Post treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
Study officials:
affiliation: Rockefeller University
name: Robert B Darnell, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frank MO, Kaufman J, Parveen S, Blachere NE, Orange DE, Darnell RB. Dendritic cell vaccines containing lymphocytes produce improved immunogenicity in patients with cancer. J Transl Med. 2014 Dec 5;12:338. doi: 10.1186/s12967-014-0338-3.
Clinical trial NCT03484793: Reduce Medication Errors by Translating AESOP Model Into CPOE Systems
Official title: Using Big Data and Deep Neural Network to Prevent Medication Errors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: AESOP Model
Big data
medication error
data mining
patient safety
CPOE
CDSS
alarm fatigue
association rule mining.
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
name: Taipei Medical University Shuang Ho Hospital
name: Taiwan College of Healthcare Executives
name: Taipei Medical University Taipei Municipal Wan Fang Hospital
name: Case Western Reserve University
name: Cardinal Tien Hospital
name: Yong He Cardinal Tien Hospital
name: Chang Hua Christian Hospital
name: Taipei Medical University Hospital
First posted: 2018-04-02
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Medication errors are common, life-threatening, costly but preventable. Information technology and automated systems are highly efficient for preventing medication errors and therefore widely employed in hospital settings. In this study, investigators would perform a cluster randomized controlled trial of a clinical reminding system that uses DNN and Probabilistic models to detect and notify physicians of inappropriate prescriptions, giving them the opportunity to correct these gaps and increase prescriptions completeness. This study aim is to assess whether or not this system would improve prescription notation for a broad array of patient conditions.

Detailed description: This paper focuses on "Big data" in the knowledge base, using "Data minig" study of DM (Disease-Medication) and MM (Medication-Medication) of relevance to develop associated decision resources system-"the intelligent safety system" (Advanced Electronic Safety of Prescriptions,AESOP Model), and test the system in the clinical environment in hospital can assist physicians when open orders reduce medication errors, the system is named "AESOP Model".

Eligibility criteria: Inclusion Criteria:

* Physicians who are working at the outpatient clinics in hospitals.
* Physicians who sign the consent form

Exclusion Criteria:

* Physicians who are unable to participate in this trial for the whole process
* Physicians who do not sign the consent form

Primary outcomes:
measure: The acceptance rate of reminder between two groups intervention and control
timeFrame: 3 months
Secondary outcomes:
measure: The changes in the number of reminder for each group
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: TMU-Shuang-Ho Hospital
Study officials:
affiliation: Taipei Medical University
name: Yu-Chuan MD Li, PhD
role: STUDY_CHAIR
affiliation: Taipei Medical University
name: Chuya Huang, MA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04847193: Hop Compounds and Immune System
Official title: Effect of Iso-alpha-Acids and Xanthohumol on Inflammatory Processes in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Response
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to determine the effect of Xanthohumol and Iso-alpha-acids from hops on the immune response of healthy participants.

Detailed description: In this placebo-controlled crossover study a study drink enriched with either a placebo, Xanthohumol, Iso-alpha Acids or a combination of latter is given to the participants. A washout phase before intervention and between each intervention is introduced. On day one of each intervention blood is drawn in fasted state from each participant. Subsequently the study drink combined with a standardized breakfast is given to the participants following a second blood drawing one hour after the consumption of the study drink. On the last day of each intervention blood is taken from study participants in the same manner as on day one. To assess the effect of Xanthohumol and Iso-alpha acids or a combination of both, clinical chemical parameters e.g. ALT, AST, γ-GT, blood lipids (triglycerides, total cholesterol, HDL, LDL), blood glucose, uric acid and CRP are determined. Furthermore, PBMC's isolated from blood samples of each time point were stimulated for either 24 or 48 h. Protein levels and mRNA expression of markers of inflammation is measured in PBMC's and supernatant of stimulated cells.

Eligibility criteria: Inclusion Criteria:

* healthy, normal weight,

Exclusion Criteria:

* food intolerances, food allergies, chronic inflammatory diseases, metabolic diseases, viral or bacterial infections within the last 3 weeks of inclusion, intake of immunosupressive medication

Primary outcomes:
measure: Changes in parameters of immune response
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
References:
citation: Jung F, Staltner R, Baumann A, Burger K, Halilbasic E, Hellerbrand C, Bergheim I. A Xanthohumol-Rich Hop Extract Diminishes Endotoxin-Induced Activation of TLR4 Signaling in Human Peripheral Blood Mononuclear Cells: A Study in Healthy Women. Int J Mol Sci. 2022 Oct 21;23(20):12702. doi: 10.3390/ijms232012702.
citation: Jung F, Staltner R, Tahir A, Baumann A, Burger K, Halilbasic E, Hellerbrand C, Bergheim I. Oral intake of xanthohumol attenuates lipoteichoic acid-induced inflammatory response in human PBMCs. Eur J Nutr. 2022 Dec;61(8):4155-4166. doi: 10.1007/s00394-022-02964-2. Epub 2022 Jul 20.