louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00720993: Colorectal Cancer Screening Validation Study
Official title: Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer Screening
Keywords: Colorectal cancer screening
Gene expression
RTPCR
Lead sponsor: IntelliGeneScan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: BiotechNiks / Molecular Medicine Research Institute
First posted: 2008-07-23
Enrollment: 165
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing routine colonoscopy screening or patients scheduled for colorectal cancer surgery.

Brief summary: The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal cells collected through the use of a standard anoscope and cytology brush. Patients will include those scheduled for routine colonoscopy procedures and those with confirmed colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* willing to provide informed consent
* greater than or equal to 50 years of age
* patient is scheduled for routine colonoscopy procedure or colorectal cancer surgery
* subject is willing to provide colorectal mucosal sample for gene expression testing

Exclusion Criteria:

* recent radiation or treatment for gynecologic, prostate or rectal cancer
* recent surgery for anal rectal disease
* polys, family or self history of cancer (control group only)
* GI disease
* any mucosal disease or systemic condition that may confound the scientific interpretation of the gene expression results

Primary outcomes:
measure: - To select a threshold for Mahalanobis distance to determine the best operating characteristics (sensitivity and specificity) in subjects with cancer and subjects without cancer. - To explore other empirical metrics based on previous exploratory data
timeFrame: Mai 2009
Secondary outcomes:
measure: - To obtain data to estimate sensitivity, specificity, and the ROC curve for a test based on M-distance. - To determine the variability of sensitivity and specificity estimates
timeFrame: Mai 2009
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT01370993: The Prediction Model of Hypoxemia for Safe Bronchoscopy
Official title: The Prediction Model of Hypoxemia for Safe Bronchoscopy Under MAC Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoxemia
Obstructive Sleep Apnea
Keywords: Hypoxemia
Model
Bronchoscopes
Monitored anesthesia care
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-06-10
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patienst who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital

Brief summary: The purpose of this study is to develop the hypoxemia prediction model during fiberoptic bronchoscopy under MAC(monitored anesthesia care) anesthesia.

Detailed description: Currently, diverse sedatives and analgesic methods are used during fiberoptic bronchoscopy for reducing patients' discomfort and facilities of procedures as British Thoracic Society recommendation. MAC anesthesia, one of the widely used sedative method during bronchoscopy, have many advantages, occurrence of respiratory depression, hypoxemia are not uncommon during the procedures. The investigators try to find out risk factors and develop the prediction model for hypoxemia during bronchoscopy under MAC anesthesia.

Eligibility criteria: Inclusion Criteria:

* Age\> 15 yrs
* patients who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital

Exclusion Criteria:

* Patients who will get Endobronchial ultrasound guided transbronchial needle aspiration
* patients whose baseline oxygen saturation is below 90%
* Intubated patients
* Patients do not agree with the study enrollment

Primary outcomes:
measure: Lowest oxygen saturation during bronchoscopy, development of hypoxemia(SpO2<90%) during bronchoscopy
timeFrame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
Secondary outcomes:
measure: Need for oxygen flow increment
timeFrame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
measure: the proportion of subjects who is require of mandible lift
timeFrame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
measure: time delay for procedure due to hypoxemia
timeFrame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
measure: the proportion of subjects with snoring
timeFrame: during the fiberoptic bronchoscopy, estimated procedure time is about 15min
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Sei Won Lee
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sei Won Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01805193: Myocardial Blood Flow by 15O Water PET
Official title: Validation of Computed Tomography Myocardial Perfusion Imaging Using Quantification of Myocardial Blood Flow by Positron Emission Tomography With 15O-water
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Coronary heart disease
computed tomography myocardial perfusion
positron emission tomography
oxygen 15 labelled water
myocardial perfusion
myocardial blood flow
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with suspected coronary heart disease

Brief summary: Coronary heart disease is a very common condition caused by narrowings in the blood vessel supplying the heart. the investigators are studying new tests to diagnose heart disease. In this study the investigators plan to investigate a special scan called a PET/CT (Positron emission tomography/computed tomography) and a new type of CT (Computed tomography) scan to tell us about the flow of blood to the heart muscle.

Detailed description: Participants will undergo PET/CT with oxygen-15 labelled water and computed tomography myocardial perfusion imaging.

Eligibility criteria: Inclusion Criteria:

* suspected coronary artery disease

Exclusion Criteria:

* inability or unwillingness to undergo CT or PET imaging
* renal failure (serum creatinine \>200 um/L or eGFR \<30 ml/min)
* hepatic failure
* allergy to iodinated contrast
* pregnancy
* contraindication to adenosine
* inability to give informed consent
* atrial fibrillation with a fast ventricular rate (\>70 beats per minute)

Primary outcomes:
measure: Myocardial blood flow
timeFrame: 1 month
Secondary outcomes:
measure: Fractional flow reserve
timeFrame: 1 month
measure: Myocardial perfusion
timeFrame: 1 month
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Clinical Research Imaging Centre
state: Scotland
Study officials:
affiliation: University of Edinburgh
name: David Newby, PhD DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00472511: Study of Eyes and Attention Deficit (SEAD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ADHD
Convergence Insufficiency
Accommodative Insufficiency
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 75
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Attention-Deficit Hyperactivity Disorder (ADHD) is considered to be one of the most prevalent chronic health conditions in children. It affects between 4% and 12% of young children. A relationship between convergence insufficiency (eye teaming) and ADHD has been shown. However, the effect of ADHD medications on focusing and eye teaming has not been previously investigated. Therefore, the purpose of this study is to determine the effect of ADHD medication on focusing and eye teaming skills.


Eligibility criteria: Inclusion Criteria:

* Best corrected visual acuity of 20/25 in both eyes at distance and near;
* Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary;
* 500" random dot stereopsis

Exclusion Criteria:

* Amblyopia (lazy eye);
* Eye disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Levelle Jenkins, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Marjean Kulp, OD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01941511: A Study to Evaluate the Effect of IV Doses of GMI-1070 on Qtc Intervals in Healthy African-American Adult Subjects
Official title: A Phase 1, Randomized, 3-way, Crossover Single Dose, Placebo, and Active Controlled Study to Evaluate the Effect of Intravenous Doses of GMI-1070 on Qtc Intervals in Healthy African-American Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: QTc
African-American
GMI-1070
QT/QTc interval prolongation
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
First posted: 2013-09-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of GMI-1070 in African-American Adult subjects. This is conducted as part of standard drug development.

Detailed description: Safety

Eligibility criteria: Inclusion Criteria:

* Healthy African-American male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

* Pregnant females; breastfeeding females; and females of childbearing potential. Males who are unwilling or unable to use 2 highly effective method of contraception for the duration of the study starting at least 14 days prior to the first dose of investigational product and for at least 28 days after the last dose of investigational product.
* Non African-American.
* 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 the time of dosing).

Primary outcomes:
measure: QTc, during rivipansel treatment period
timeFrame: prior to dose, through 72 hours after dosing
measure: QTc, during placebo treatment period
timeFrame: prior to dose, through 72 hours after dosing
Secondary outcomes:
measure: QTc, during moxifloxacin treatment period
timeFrame: prior to dose, through 72 hours after dosing
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02868411: Improving the Diagnosis of Traveller's Fevers in Point Of Care (POC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traveller's Fever
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 159
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of traveller's fever caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC traveller's fever tests .

The objective of this study is to implement a new diagnosis strategy relying on the hypothesis that a rectal swab would improve the etiological diagnosis of traveller's fever of at least 10%.


Eligibility criteria: Inclusion Criteria:

* Patient admitted for traveller's fever requiring a microbiological examination with a "Traveller's fever POC kit"
* Patient who freely signed the informed consent form
* Patient affiliated to a social security regime

Exclusion criteria

* Pregnant or breastfeeding women
* Adult patient under guardianship
* Patient deprived with liberty under court order
* Patient refusing or unable to sign the informed consent form

Primary outcomes:
measure: Percentage of patients admitted for traveller's fever with a confirmed etiological diagnosis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT02041611: Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
Official title: Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Grade Glioma
Keywords: WHO grade III and IV
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2014-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary goal of this study is evaluate T cell immune status and immune reconstitution and the association with specific cytokines in patients with newly diagnosed HGGs undergoing the standard RT/TMZ and adjuvant TMZ.

Detailed description: Numbers of T-cell subtypes at six time points in patients with newly diagnosed HGGs undergoing standard RT/TMZ and adjuvant TMZ:

1. Baseline within 2 weeks before initiation of RT/TMZ
2. At the end of RT/TMZ approximately week 6
3. Before adjuvant TMZ approximately week 10
4. After 2 cycle of TMZ approximately week 18
5. After 4 cycle of TMZ approximately week 26
6. Three month after last cycle of TMZ

Secondary Endpoints

1. Changes in serial T cell subtypes and cytokines levels
2. Incidence of lymphopenia related infections
3. Changes in T-cell numbers and subtypes with TMZ administration
4. Overall survival

Eligibility criteria: Inclusion Criteria:

1. Patients must be at least 18 years of age.
2. Patients must have histologically confirmed new diagnosed high grade glioma by pathology (WHO grade III and IV).
3. Patients proposed post-operative treatment plan must include standard radiation and temozolomide.
4. Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
5. Patients must be able to provide written informed consent.
6. Steroid use is allowed.

Exclusion Criteria:

1. Patients with HIV are excluded.

Primary outcomes:
measure: Changes in T Cell subtypes and cytokines as a function of treatment
timeFrame: 6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Johns Hopkins University
name: Stuart A Grossman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05324111: VaLidation of the Simple Adaptation of the Kardia 6L ECG Recorder to Obtain Chest leAd equivaLents: a Multi-centre International (LOCAL-ECG) Study; on Behalf of the Africa Heart Rhythm Association Investigators
Official title: VaLidation of the Simple Adaptation of the Kardia 6L ECG Recorder to Obtain Chest leAd equivaLents: a Multi-centre International (LOCAL-ECG) Study; on Behalf of the Africa Heart Rhythm Association Investigators
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs. The aim is to test whether a novel adaptation to a handheld ECG recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier diagnosis and treatment and has implications in the prevention of infection.

The lead author recently published a pilot study showing the clinical utility of this technique and the aim of this study is to validate the method.


Eligibility criteria: Inclusion Criteria:

* Any patient who is attending the cardiology clinic or an inpatient on the cardiology ward who consents to taking part

Exclusion Criteria:

* Patients who are unable or refuse to consent

Primary outcomes:
measure: Sensitivity and specificity of adaptation to handheld 6Lead
timeFrame: 10 Minutes
Secondary outcomes:
measure: Assessment of other ECG parameters
timeFrame: 10 Minutes
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
Study officials:
References:
Clinical trial NCT01116011: Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers
Official title: A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Japanese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Japanese Healthy volunteer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.


Eligibility criteria: Inclusion Criteria:

* Provision of Informed Consent
* Healthy male subjects, with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

* Inability to understand or cooperate with given information
* Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
* History of seizure (including infant febrile seizures) or family history of seizure

Primary outcomes:
measure: Investigate the safety and tolerability of AZD7268 by Adverse Events.
timeFrame: From first dosing throughout the treatment period and including the follow-up period
Secondary outcomes:
measure: Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma
timeFrame: Blood samples will be taken from pre-dose until 48 hours post last dose
measure: Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine
timeFrame: Urine samples will be taken from post first dose until 48 hours post last dose.
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: Research Site
state: Sagamihara
Study officials:
affiliation: Kitasato University East Hospital, Kanagawa, Japan
name: Tomoe Fujita
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04836611: Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)
Official title: Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Consumption of Cannabis
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The Cannabinoide Hyperemesis Syndrom (CHS) is defined as a recurrent syndrome of intractable vomiting that occurs in chronic cannabis consumers. The diagnosis is linked to clinical criteria only. The physiopathology of CHS is unknown and we observe an increase of cases with this syndrom since 2016 (Schreck et al., 2018).

The aim of this study is to investigate the involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS.


Eligibility criteria: Inclusion Criteria:

* Subjects without protection by a legal regime (guardianship, trusteeship)
* Subjects affiliated to an appropriate social security system
* Subjects must sign an informed consent form

Inclusion Criteria for Group 1:

- Subjects must have the CHS diagnosis confirmed

Inclusion Criteria for Group 2:

- Subjects must be chronic cannabis consumers and never had CHS

Exclusion Criteria:

* Subjects must not have addictive comorbidities or psychoactive substance abuse (except alcohol and tabacco)

Primary outcomes:
measure: involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS (see details below for exogenous cannabinoids)
timeFrame: on the day of subjects inclusion
measure: THC (Tetrahydrocannabinol)
timeFrame: on the day of subjects inclusion
measure: metabolite of THC : THC-OH (11-hydroxy-Δ⁹-tétrahydrocannabinol)
timeFrame: on the day of subjects inclusion
measure: metabolite of THC : THC-COOH (11-nor-9-carboxy-Δ⁹-tétrahydrocannabinol)
timeFrame: on the day of subjects inclusion
measure: CBD (Cannabidiol)
timeFrame: on the day of subjects inclusion
measure: CBN (Cannabinol)
timeFrame: on the day of subjects inclusion
measure: CBG (Cannabigerol)
timeFrame: on the day of subjects inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU
Study officials:
References: