louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02579434: Evaluation and Validation of Endogenous Markers for the Assessment of CYP3A Activity in Korean Healthy Subjects Using Metabolomics
Official title: Evaluation and Validation of Endogenous Markers for the Assessment of CYP3A Activity in Korean Healthy Subjects Using Metabolomics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: CYP3A
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study objective is to evaluate and validate of endogenous markers for the assessment of CYP3A activity in Korean healthy subjects using metabolomics.

In part 1, total 75 healthy subjects (males and females) will be enrolled. In part 2, total 25 healthy female subject aged 20-45 years will be enrolled. In both part A and B, subjects will be administered midazolam I.V. 1 mg.


Eligibility criteria: Inclusion Criteria:

* Age: Between 20 to 80 years of age, inclusive
* Weight: Between 45 to 95 kg, within 17 - 28 of Body Mass Index
* Subject who agree contraception during the study
* Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria:

* History of hypersensitive reaction to medication (midazolam, ketoconazole, rifampicin)
* History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease history or evidence of drug abuse
* A subject whose lab test results are abnormal A subject whose systolic blood pressure is over 140 mmHg or below 90 mmHg and diastolic blood pressure is over 100 mmHg or below 50 mmHg
* Presence or history of drug abuse or positive result in urine drug screening test
* Blood donation during 2 months or apheresis during 1 month before the study Use any prescriptive medication
* Use of alcohol over 21 units/weeks
* Smoker who smoke more than 10 cigarettes per day
* Participation in clinical trials of any drug within 60 days prior to the participation of the study
* Use of grapefruit juice within 1 week before first dose
* Use of caffeine drink within 3 days before first dose
* Subject pregnant or breast-feeding
* Judged to be inappropriate for the study by the investigator

Primary outcomes:
measure: Area under the curve of midazolam (AUC12h)
timeFrame: Up to 12 hours after midazolam administration
measure: Metabolic ratio of steroids
timeFrame: 12h-12h
measure: Clearance (CL) of midazolam
timeFrame: Up to 12 hours after midazolam administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jieon Lee
Study officials:
References:
Clinical trial NCT05445817: Pulmonary Care and Research Collaborative Patient Registry
Official title: Pulmonary Care and Research Collaborative Patient Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease
Keywords: Progressive Fibrosing Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease Associated With Systemic Sclerosis
Myositis-Associated Interstitial Lung Disease
Sarcoidosis
Hypersensitivity Pneumonitis
Pulmonary Fibrosis
Lead sponsor: Pulmonary Care and Research Collaborative Limited
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2022-07-06
Enrollment: 150
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: People with a confirmed diagnosis of interstitial lung disease by a primary care physician and/or pulmonologist.

Brief summary: The purpose of this research study is to build and maintain a registry of people with interstitial lung disease (ILD). Medical information collected for this registry may be used to advance ILD and pulmonary research and improve patient care. This is an observational registry. Participants will not receive any investigational treatments or investigational drugs as part of their participation in this registry.

Detailed description: The registry will contain longitudinal medical histories of ILD patients. The creation and curation of the registry with utilize release of information services, biomedical informatics methods and human expert reviews. Among the registry's long-term goals is to utilize its data and informatics resources to study and advance ILD diagnosis and treatment. The registry will be developed with a set of capabilities to consistently, repeatedly, and economically build research-grade datasets that allow cohort development from natively unstructured and non-standard phenotypic clinical and imaging data.

Eligibility criteria: Inclusion Criteria:

* People with a confirmed diagnosis of interstitial lung disease by a primary care physician and/or pulmonologist.

Exclusion Criteria:

-

Primary outcomes:
measure: Development and implementation of a database populated with de-identified longitudinal medical histories of interstitial lung disease patients.
timeFrame: Up to 18 months
Secondary outcomes:
measure: Advancing the understanding of the natural course and the treatments of interstitial lung diseases.
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Pulmonary Care and Research Collaborative, Ltd.
state: Massachusetts
Study officials:
affiliation: Pulmonary Care and Research Collaborative, Ltd.
name: Aliaa Barakat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06882317: Long Term Follow-up Study for Subjects Administered CLBR001
Official title: A Study to Evaluate the Long Term Safety of CLBR001, a Lentiviral Based Chimeric Antigen Receptor, in Subjects Previously Administered CLBR001
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Long Term Follow-Up
Keywords: Long Term Follow-Up (LTFU)
CLBR001
Autologous Cell Therapy
Switchable CAR-T Cell
Cell and Gene Therapy
Lead sponsor: Calibr, a division of Scripps Research
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received CLBR001.

Brief summary: The goal of this Long Term Follow-Up observational study is to monitor subjects who have received CLBR001, a lentiviral vector based chimeric antigen receptor, for delayed adverse events that may be associated with human gene therapies.

Participants will be followed for 15 years post-gene therapy administration date for safety and efficacy.

Detailed description: In line with FDA guidance on Long Term Follow-Up (LTFU) after administration of human gene therapy products, any subject who receives CLBR001 on any Calibr treatment study will participate in LTFU on this study. Subjects will be enrolled following completion on the applicable treatment study and followed for 15 years post-CLBR001 administration in order to assess the long term safety of CLBR001.

Eligibility criteria: Inclusion Criteria:

* Subjects who received at least one CLBR001 cell dose.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of subjects with adverse events as assessed by CTCAE v5.0.
timeFrame: To 15 years post-CLBR001 administration.
measure: Number of subjects with replication competent lentivirus (RCL).
timeFrame: To 15 years post-CLBR001 administration.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Calibr-Skaggs Institute for Innovative Medicines
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT04325217: Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
Official title: Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 586
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: As this is a non-interventional study, no specific treatment is mandated or withheld from the patients. No limitations are set up on background factors and their concomitant drugs in use of actual medical practice.

Brief summary: The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients with SSc-ILD.


Eligibility criteria: Inclusion Criteria:

* Patients in Japan with SSc-ILD who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Incidence of adverse drug reactions (ADRs)
timeFrame: up to 3 years and 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd.
Study officials:
References:
Clinical trial NCT01045317: A Study To Investigate The Clearance Of PF-04776548 From The Body Following A Very Low (Micro) Dose Of The Compound Using A Low Level Of Radiotracer To Help Quantify Expected Low Concentrations Of PF-04776548 In The Body
Official title: An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of [14-C]-PF-04776548 In Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Immunodeficiency Virus (HIV)
Keywords: micro-dose
pharmacokinetics
open label
PF-04776548
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the pharmacokinetics of PF-04776548 following administration of a micro-dose of PF-04776548 via both intravenous and oral routes.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 65 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Primary outcomes:
measure: Pharmacokinetics: For IV dosing: Cmax, Tmax, AUClast, AUCinf, t½, CL, Vss. For oral dosing: Cmax, Tmax, Tlag, AUClast, AUCinf, t½, CL/F, Vz/F, F.
timeFrame: 14 days
Secondary outcomes:
measure: Safety and toleration: adverse events will also be reported.
timeFrame: 14 days
Other outcomes:
Locations:
city: Ruddington Fields
country: United Kingdom
facility: Pfizer Investigational Site
state: Nottingham
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00599417: PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
Official title: Prospective, Pivotal Unicentre, Randomized Double-bind, Placebo-controlled Study, to Evaluate Efficacy and Safety of Bacterial Lysates (Pulmonarom) in the Prevention of Respiratory Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Tract Infections
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary

- To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment

Secondary

* To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment
* To evaluate loss of working or study days after second period of treatment
* To evaluate the safety and tolerability of Pulmonarom in the population under study


Eligibility criteria: Inclusion Criteria:

* Patients with history of relapse or recurrence of respiratory infections or disease
* Patients with chronic respiratory disease as asthma, bronchitis or sinusitis

Exclusion Criteria:

* Patients unlikely to comply with the protocol, for example, uncooperativeness or impossibility to return for follow-up visits
* Patients who are participating or who have participated in another clinical trial during the previous 3 months
* Patients who have received immunology response stimulants during the previous 30 days
* Hypersensitivity

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Decrease of interleukin-4/interferon gamma index at baseline values
timeFrame: 60 days, 120 days
Secondary outcomes:
measure: Adverse events and laboratory evaluation
timeFrame: 120 days
Other outcomes:
Locations:
city: Col. Coyoacan
country: Mexico
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Judith Diaz
role: STUDY_DIRECTOR
References:
Clinical trial NCT01415817: Endoscopic Quality Improvement Program
Official title: The Effect of an Intensive Endoscopic Quality Improvement Program (EQUIP) on Improved Detection and Classification of Non-polypoid (Flat and Depressed) and Polypoid Colorectal Adenomas. ("EQUIP" Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenomatous Polyps
Colorectal Polyps
Keywords: Quality Improvement
Adenoma Detection Rate
Polyp detection rate
Colonoscopy
Training
Colorectal cancer screening
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Effective colorectal cancer (CRC) screening relies on early identification and removal of both polypoid and non-polypoid lesions with neoplastic potential. The investigators hypothesize that an intensive training program designed to enhance both recognition and classification of lesions with neoplastic potential, will result in an increase in non-polypoid adenoma detection in addition to and independent of an increase in overall adenoma detection rates.

Detailed description: Our Endoscopic Quality Improvement Program (EQUIP) was a prospective educational intervention with our staff endoscopist as our study population. The investigators measured adenoma detection rates for a baseline period then randomly assigned half of the endoscopists to undergo EQUIP training. The investigators then examined baseline and post-training study adenoma detection rates (ADR's) for all endoscopist (trained and un-trained) to evaluate the impact of training.

Eligibility criteria: Inclusion Criteria:

* Colonoscopies performed at Mayo clinic ambulatory surgical center

Exclusion Criteria:

* Procedures for the indication of acute GI hemorrhage
* Active colitis
* Hereditary polyposis syndrome
* Inflammatory bowel disease
* Incomplete procedures
* Procedures with surgically altered anatomy (i.e. prior colectomy)
* Poor bowel preparation (Boston Bowel preparation score \<5) were also excluded.

Primary outcomes:
measure: Measurement of overall adenoma detection rate
timeFrame: 1 year
Secondary outcomes:
measure: Measurement of total polypectomy rate
timeFrame: 1 Year
measure: Measurement of colonoscopy time
timeFrame: 1 Year
measure: Endoscopist Acceptance
timeFrame: 1 Year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael B. Wallace, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02479217: Safety of Xeloda in Solid Tumours
Official title: Safety of Xeloda in Solid Tumours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer, Colon Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 1268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with early or metastatic colon cancer, and patients with metastatic breast cancer, no age limit

Brief summary: The primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel.


Eligibility criteria: Inclusion Criteria:

Metastatic Breast Cancer:

* women \>=18 years of age
* Patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
* Previous therapy should have included an anthracycline.
* Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
* Female patients with histopathologically proven metastatic breast cancer
* Adequate bone marrow, liver, renal and cardiac functions

Colon Cancer:

* Patients \>18 years of age
* Patients with histologicaly confirmed colon cancer
* Patients with potential curative tumor resection within 8 weeks before enrolment in the study
* Patients previously not treated with chemiotherapy

Exclusion Criteria:

Metastatic Breast Cancer:

* Patients previously treated with docetaxel (Taxotere) or capecitabine (Xeloda)
* Patients with contraindications for any of study drugs as listed in approved SmPC

Colon Cancer:

* Patients previously treated with chemiotherapy
* Patients with contraindications for study drug as listed in approved SmPC

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: within 18 months
Secondary outcomes:
measure: Disease free survival (DFS)
timeFrame: within 18 months
Other outcomes:
Locations:
city: Sremska Kamenica
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01324817: Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates
Official title: Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiration
Keywords: Non-Contact
Radar
Doppler
Respiratory
Respiration
Breathing
Rate
Frequency
Respiratory Mechanics
Respiratory Rate Measurement
Apnea
Sleep Apnea
Lead sponsor: Kai Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 50
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates hospitalized at the Kapiolani Medical Center for Women and Children located in Honolulu, HI

Brief summary: The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.

Detailed description: The purpose of this study is to test two remote, Doppler radar-based sensors to measure and monitor respiratory rate. Specifically, in clinically stable neonatal patients the study aims to:

1. Obtain respiratory effort data of neonatal patients with remote Doppler radar systems modified from a system cleared by the FDA for adult use.
2. Determine if remote Doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems.
3. Determine if unattended Doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients.

Eligibility criteria: * Inclusion Criteria:

  1. Clinically stable
* Exclusion Criteria:

  1. Clinically unstable
* Hypotensive requiring pressors
* Intubated

  2. Scheduled or planned (e.g., CT scan, central line placement) procedure during the study period.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
Study officials:
affiliation: Kapiolani Medical Center For Women & Children
name: Venkataraman Balaraman, MD
role: PRINCIPAL_INVESTIGATOR
References: