louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04467281: A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma
Official title: A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: CD38-Targeted ImmunoPET
20-098
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a phase II clinical trial.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if using the radioactive tracer 89Zr-DFO-daratumumab with PET/CT scans is a practical and effective way to view and monitor multiple myeloma in participants before and during their treatment with daratumumab. We also want to see if 89Zr-DFO-daratumumab PET/CT scans can predict a participant's response to therapy, and if they can better locate any leftover disease following treatment compared to the standard imaging methods.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 21 years
* Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma
* At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment
* ECOG performance status 0 to 2
* Participant is capable of having an informed consent discussion (Legally Authorized Representatives are not permitted to sign on a participant's behalf).

Exclusion Criteria:

* Life expectancy \< 12 months
* Pregnancy or lactation
* Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
* History of anaphylactic reaction to humanized or human antibodies.
* Previous treatment with daratumumab. Previous treatment with other myeloma therapies will be allowed.

Primary outcomes:
measure: number of patient's with positive tumors
timeFrame: 1 year
Secondary outcomes:
measure: assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marius Mayerhoefer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00662181: Follow-up on the HIGH: Low Study - the Longterm Effects of Growth Hormone
Official title: Follow-up on the HIGH: Low Study - the Longterm Effect of Growth Hormone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
HIV-Associated Lipodystrophy Syndrome
Keywords: growth hormone
quality of life
fat redistribution
sugar metabolism
fat metabolism
cytokines
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from the HIGH: low study

Brief summary: A follow-up study on the randomized, controlled, double-blind HIGH: low study. We will examine the participants from the HIGH: low study min. 6 months after finishing the HIGH: low study. We will look at the parameters: quality of life, sugar-metabolism, fat-metabolism, fat-redistribution and cytokines. The study will use the participants control visit, and the only additional examination will be the danish MOS-HIV questionnaire.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* Participated in and completed the HIGH: low study
* informed consent signed

Exclusion Criteria:

* Patient stopped at Hvidovre Hospital, or didn't finish the HIGH: low study

Primary outcomes:
measure: Quality of life
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Metabolism
timeFrame: 6 months follow-up
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Klinisk Forskningscenter, Hvidovre Hospital
Study officials:
affiliation: Klinisk Forskningcenter, Hvidovre Hospital
name: Ove Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01568281: Bioequivalence Study Comparing Arimidex Tablet and Anastrozole ODF in Japanese Healthy Male Subjects
Official title: A Randomised, Open Label, Single Centre, 2 Way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Pharmacokinetics
Keywords: Bioequivalence
pharmacokinetics
safety
anastrozole
Arimidex
Japanese
healthy subject
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 58
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet after a single oral administration of each anastrozole formulation.

Detailed description: A Randomised, Open label, Single centre, 2 way Crossover Bioequivalence Study Comparing Arimidex Tablet 1 mg and Anastrozole Orally Rapid Disintegration Film Formula 1 mg After Single Oral Administration in Japanese Healthy Male Subjects

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures Japanese healthy male subjects aged 20 to 45 years Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product Have a body mass index (BMI) between 18 and 27 kg/m2

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness, medical/surgical procedure or trauma
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results

Primary outcomes:
measure: Investigation whether anastrozole ODF is bioequivalent with Arimidex tablet.
timeFrame: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose
Secondary outcomes:
measure: Evaluation of the pharmacokinetic properties of Arimidex tablet and anastrozole ODF following a single oral dose.
timeFrame: Blood samples are taken repeatedly for 24 hours and also taken occasionally up to 168 hours after each dose
measure: Evaluation of the safety and tolerability of Anastrozole ODF 1 mg.
timeFrame: Safety variables are measured prior to treatment and up to 14 to 17 days (follow-up) after the last dose. Subjects will be monitored throughout the study for adverse events
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Japan
name: Eisei Shin, MD
role: STUDY_DIRECTOR
affiliation: Kyushu Clinical Pharmacology Research Clinic
name: Kyoko Matsuguma, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01865695: Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase
Official title: Randomized, Double Blind, Placebo-controlled Trial of Creon in Patients With Low Faecal Pancreatic Elastase
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)
Patients With Pancreatic Exocrine Insufficiency
Keywords: pancreatic exocrine insufficiency
faecal elastase
diarrhoea
coeliac
creon
gastrointestinal
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 2
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine insufficiency. This condition manifests with symptoms of diarrhea, weight loss, causing potential impairment on an individual's quality of life. Creon, a pancreatic enzyme supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for this condition. However, there has been limited work evaluating the merits of this medication in this condition. This study aims to evaluate the benefits that Creon may have in coeliac patients with low faecal pancreatic elastase by randomising patients with low faecal pancreatic elastase (\<200 ug/g) to either treatment with Creon or placebo. Outcome measures that we aim to assess to determine the benefits of Creon include evaluation of stool frequency, abdominal pain, body mass index (BMI) and quality of life.


Eligibility criteria: Inclusion Criteria:

* patients with coeliac disease and having chronic diarrhoea (\>3 loose/ liquid motions a day for more than 4 weeks)
* Patients with a low faecal elastase (\<200 ug/g),
* Patients aged 16 years or over
* Patient able to give written consent to participate
* Patient not currently on Creon

Exclusion Criteria:

* Patients with normal faecal elastase (\> 201ug/g),
* Patients under the age of 16
* Patients allergic to pork or any pig product (advice from the drug manufacturer)
* Patients that are pregnant or are breast-feeding
* Patients taking alternative medication that could affect bowel frequency
* Where an alternative diagnosis for the chronic diarrhoea is established, these patients will be excluded from the trial
* Patients who are unable to speak or understand English

Primary outcomes:
measure: Stool frequency in patients with low faecal pancreatic elastase following six weeks of treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 6 weeks
measure: body mass index
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Department of Gastroenterology
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: David S Sanders, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04825795: DPP4 Inhibitor and Coronary Atherosclerosis in Patients Receiving Insulin Therapy
Official title: Effect of DPP4 Inhibitors on Coronary Atherosclerosis in Patients With Diabetes Mellitus on Insulin Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 4007
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with diabetes mellitus and receiving chronic insulin therapy will be enrolled. Among those, only patients who underwent more than two times of coronary CT scan will be included.

Brief summary: The study aim is to evaluate whether DPP4-inhibitor could reduce coronary atherosclerosis assessed by CT scan in patients receiving insulin for diabetes mellitus. In this retrospective study, changes in obstructive coronary artery disease prevalence and coronary calcium burden between two coronary CT scans will be compared in patients with and without receiving DPP4-inhibitor.

Detailed description: This is a retrospective study using medical records in two hospitals affiliated to the Catholic University of Korea. Patients with diabetes mellitus who received insulin are retrospectively enrolled. Among those, only patients who underwent coronary CT scan for more than two times will be included. Included patients will be classified into DPP4-inhibitor group and no DPP4-inhibitor group according to the prescribed medication. The changes in obstructive coronary artery disease prevalence and coronary calcium score per one year will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus
* Receiving chronic insulin therapy (prescription of insulin pen)
* Who underwent more than 2 times of coronary CT scan

Exclusion Criteria:

* Age \<18

Primary outcomes:
measure: Prevalence of obstructive coronary disease
timeFrame: one year
Secondary outcomes:
measure: Change in coronary calcium score
timeFrame: one year
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital
Study officials:
affiliation: Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea
name: Sang-Hyun Ihm, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00252395: Evaluation of Electronic Prescribing in Hospital Ambulatory Care Clinics
Official title: Effects of Electronic Prescribing on Safety and Quality in Hospital-Based Ambulatory Are: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Electronic Prescribing
Keywords: medication error
electronic prescribing
patient safety
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Health Canada
First posted: 2005-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: All reliably evaluated POE systems to date have been desktop computer based, but now there is widespread use and acceptance among physicians of PDA devices for a variety of purposes. Clinicians report that drug information on a PDA improved their access to information and efficiency while reducing their self perceived error rates6. The use of these devices for information retrieval in clinical settings is expected to grow as wireless communication becomes more ubiquitous and as more applications become available6,7. During the past decade there has been a growing awareness of several issues aimed at promoting safer health care for our patients - point of care information technology is one of the keys.

To this end we have worked with a Canadian company, Drugmagnet, to develop and implement PDA-based electronic prescribing system within a major Canadian academic health centre. This is a cluster randomised trial, in which access to and use of the e-prescribing system is switched on and off for randomly chosen weeks, thus time serves as the randomized element.


Eligibility criteria: Inclusion Criteria:

* active staff physician at Sunnybrook \& Women's College HSC

Exclusion Criteria:

* inadequate prescribing practice (minimum number)

Primary outcomes:
measure: Total prescribing error, as measured by the number of call backs received from pharmacists.
Secondary outcomes:
measure: a) Interactions
measure: b) Dosing and route of administration errors
measure: c) Pack errors
measure: d) Legibility errors
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Science Centre
state: Ontario
Study officials:
affiliation: Institute for Clinical Evaluative Science
name: Merrick F Zwarenstein, MBBCH
role: STUDY_DIRECTOR
affiliation: Sunnybrook & Women's College Health Sciences Centre
name: William J Sibbald, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dainty KN, Adhikari NK, Kiss A, Quan S, Zwarenstein M. Electronic prescribing in an ambulatory care setting: a cluster randomized trial. J Eval Clin Pract. 2012 Aug;18(4):761-7. doi: 10.1111/j.1365-2753.2011.01657.x. Epub 2011 Mar 18.
citation: Zwarenstein MF, Dainty KN, Quan S, Kiss A, Adhikari NK. A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting. Trials. 2007 Oct 3;8:28. doi: 10.1186/1745-6215-8-28.
Clinical trial NCT04947995: Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer
Official title: Validation of a Plasma-based Multiomics Assay and Risk Scoring Model for Screening of Gastric Malignancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Lead sponsor: GeneCast Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2021-07-01
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged≥40 who will receive EGD.

Brief summary: This is a prospective, case-control study intended to develop and validate a blood-based multi-omics assay and computational model for early detection of gastric cancer. Approximately 450 subjects who receive esophageogastroscopy (EGD) will be enrolled and assigned to three arms including gastric cancer, precancerous lesion, and healthy control based on the diagnosis of EGD and histological results. Cell free DNA will be extracted from peripheral blood of all participants and assayed by next-generation sequencing for biomarkers including somatic mutation, methylation, and chromosome instability signals. In the first stage a multi-omics models will be developed for classification between malignancy group and control groups, and between precancerous group and healthy control. Sensitivity and specificity of the model will be evaluated in an independent validation group in the second stage.


Eligibility criteria: Inclusion Criteria:

* Age≥40
* Received EGD;
* Subjects must have given written informed consent, and the subjects compliance are good.

Exclusion Criteria:

* Subjects who could not accept EGD;
* Subjects who had previously undergone total or partial gastrectomy;
* There are other serious acute or chronic medical or mental diseases or laboratory abnormalities that may interfere with the interpretation of the research results and make the subjects unsuitable for the study in the judgment of the researchers;
* Subjects with a history of malignant tumor or two or more malignant tumors at the same time;
* Pregnant subjects;
* Subjects who had a history of bone marrow or organ transplantation, or had a history of blood transfusion one month before enrollment.
* The subjects with incomplete clinical data collection or other reasons judged by the researchers are not suitable for this study.

Primary outcomes:
measure: The sensitivity and specificity of blood-based multi-omics assay for early detection of gastric cancer with comparison to EGD and/or histological diagnosis.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT04513795: EARLY-MYO-SEPSIS Registry
Official title: EARLY-MYO-SEPSIS (EARLY Assessment of MYOcardial Injury in Sepsis Patient) Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 300
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were diagnosed as sepsis or suspected as sepsis

Brief summary: The diagnosis and pathophysiology of sepsis-induced cardiac dysfunction remain unknown. This registry is to evaluate characteristics of sepsis patients by multi-modalities imaging, including echocardiography, cardiovascular magnetic resonance imaging in 300 patients in 5 sites. Subjects will be followed up to 2 years.

Detailed description: Approximately 20-30 million patients worldwide suffer from sepsis every year, which is increasing at the rate of 8% to 13% per year. It is possible that sepsis progress to multiple organ dysfunction in the early stage, with a fatality of 30% to 60%. Myocardium is one of the most vulnerable tissue under the abnormal 'inflammation storm'.Cardiac dysfunction is one of the important predictors for mortality of sepsis.Patients with myocardial depression have an apparently higher mortality rate (70%) as compared with septic patients without cardiac impairment (20%).

Although several trials had explored the diagnosis and treatment of sepsis-induced cardiac dysfunction, the effective characteristic depict and effective therapy remain incompletely understand.

This is a prospective, multi-center, non-randomized, observational registry study of sepsis patients that undergo multi-modality imaging.

Eligibility criteria: Inclusion Criteria:

* Patiants meets the criteria of Sepsis 3.0 as below:
* Sepsis is a lifethreatening organ dysfunction caused by a dysregulated host response to infection
* 1 patients in ICU：
* 1.1 have at least one organ dysfunction
* 1.2 SOFA score ≥2
* 2 patients not in ICU
* 2.1 have at least one organ dysfunction
* 2.2 SOFA score or qSOFA score ≥2

Exclusion Criteria:

* 1. Patient who is unable to comply with the follow-up schedule.
* 2. Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
* 3. Patient has a life expectancy of less than 6 months due to any condition

Primary outcomes:
measure: composite of death, stroke, heart failure
timeFrame: 2 years
Secondary outcomes:
measure: day of hospitalization
timeFrame: through study completion, 2 months
Other outcomes:
Locations:
Study officials:
References: